PHARMACEUTICAL POWDER COMPOSITION AND ITS USE IN THE CONTROL OF POST-PRANDIAL GLYCAEMIC PROFILE

Abstract

A powder composition for preparation of a drink for control of post prandial glycaemic profile, the powder composition comprising: alpha-glucosidase inhibitor selected from the group consisting of acarbose, miglitol, voglibose and mixtures thereof, in an amount in the range of from 0.01% to 15% w/w of the powder composition; viscosifying agent in an amount in the range of 5% to 30% w/w of the powder composition; protein in an amount in the range of 40% to 90% w/w of the pharmaceutical powder composition. 10

Claims

1. A powder composition for preparation of a drink for control of post prandial glycaemic profile, the powder composition comprising: alpha-glucosidase inhibitor selected from the group consisting of acarbose, miglitol, voglibose and mixtures thereof, in an amount in the range of from 0.01% to 15% w/w of the powder composition; viscosifying agent in an amount in the range of 5% to 30% w/w of the powder composition; protein in an amount in the range of 40% to 90% w/w of the pharmaceutical powder composition.

2. A powder composition according to claim 1, wherein the alpha-glucosidase inhibitor is present in an amount of 0.05% to 5% w/w of the powder composition; a viscosifying agent which is a polysaccharide in an amount in the range of 10-20% w/w of the powder composition and protein present in an amount of 50% to 80% w/w of the powder composition.

3. A powder composition according to claim 1, wherein the alpha-glucosidase inhibitor is acarbose, the viscosifying agent is a galactomannan gum and the protein is a dairy protein.

4. (canceled)

5. A powder composition according to claim 1 in the form of a unit dose for preparation of a drink for control of post prandial glycaemic profile, the unit dose powder composition comprising: from 5 mg to 250 mg of alpha-glucosidase inhibitor; protein in an amount of 8 g to 40 g; viscosifying agent in an amount of from 1 g to 8 g.

6. A powder composition according to claim 5, wherein the alpha-glucosidase inhibitor is acarbose present in an amount of from 5 mg to 100 mg.

7. A powder composition according to claim 5 dispersed in an aqueous drink of volume in the range of from 30 ml to 300 ml.

8. A powder composition according to claim 7, wherein the volume of aqueous drink is from 75 ml to 200 ml.

9. (canceled)

10. A powder composition according to claim 1 further comprising a silica based flow modifier present in the powder composition in an amount of from 0.5% w/w to 2.0% w/w of the powder composition.

11. An aqueous glucosidase inhibitor composition in the form of a drink comprising a powder composition dispersed in an aqueous liquid in ratio of weight of powder components to volume of aqueous liquid of 10-100 mg alpha-glucosidase inhibitor; 8-30 g protein; and 1.5-8 g soluble fibre; per 150 ml of aqueous liquid.

12. An aqueous alpha-glucosidase inhibitor composition according to claim 11, wherein the alpha-glucosidase inhibitor is acarbose, the protein is dairy protein and the soluble fiber is a galactomannan gum.

13. An aqueous alpha-glucosidase inhibitor composition according to claim 11, wherein the protein is whey protein and the viscosifying agent is guar gum, fenugreek gum or mixture thereof.

14. An aqueous alpha-glucosidase composition according to claim 11, wherein the composition is formulated to exhibit eccentric shear banding flow characteristics.

15. A method of controlling post-prandial glycaemic profile of a subject, comprising: providing a unit dose of powder composition comprising: alpha-glucosidase inhibitor in an amount of from 5 mg to 250 mg; protein in an amount of 8 g to 40 g; viscosifying agent in an amount of from 1 g to 8 g; combining the unit dose of powder with an amount of aqueous liquid in the range of from 75 ml to 200 ml to provide a drink composition; and the subject consuming the drink composition.

16. A method according to claim 15, wherein the drink is consumed within 30 minutes to 0 minutes (immediately before) before a meal.

17. A method according to claim 15, wherein the drink is consumed within 5 minutes of mixing the powder with an aqueous liquid.

18. A method according to claim 15, wherein the alpha-glucosidase inhibitor is acarbose in an amount of 5 mg to 100 mg, the protein is dairy protein in an amount of from 8 g to 40 g and the viscosifying agent is galactomannan gum in an amount of from 1 g to 8 g.

19. A method according to claim 15, wherein the subject is suffering diabetes or prediabetes.

20. A method according to claim 15, wherein the alpha-glucosidase inhibitor is acarbose, the protein is whey protein and the viscosifying agent is galactomannan gum.

21. A method according to claim 15, wherein the drink exhibits centric-shearbanding.

22.-23. (canceled)

24. A powder composition according to claim 5 in the form of a unit dose, wherein the viscosifying agent is present in an amount sufficient to provide an aqueous mixture of the powder with a viscosity of at least 600 cp within 15 minutes of a unit dose of the powder being mixed with 150 ml water.

Description

EXAMPLES

Brief Description of Drawings

[0071] In the drawings:

[0072] FIG. 1 is a schematic view an apparatus used to measure eccentric shear-banding in accordance with the invention showing the rotating spindle and liquid sample.

[0073] FIG. 2 is a view from above of a liquid sample prior to measurement of eccentric shear-banding with a dye mark placed 20 mm from the container wall.

[0074] FIG. 3 is a schematic view of the apparatus of FIG. 1 during measurement of eccentric shear-banding (when the rotating spindle is lowered into the liquid sample).

[0075] FIG. 4 is schematic view from above of a measurement of angle A referred to in the Quantitative definition of Eccentric shear-banding.

[0076] FIG. 5 is a schematic view an apparatus used to measure centric-shear banding in accordance with the invention showing the rotating spindle and liquid sample.

[0077] FIG. 6 is a view from above of a liquid sample prior to measurement of shear banding with dye marks placed adjacent the container wall and 20 mm from the container wall.

[0078] FIG. 7 is a schematic view of the apparatus of FIG. 5 during measurement of centric-shear banding when the spindle has been lowered into the test liquid.

[0079] FIG. 8 is a view from above of a drink sample showing the result of the shear banding test identifying angle A (25) subtended at the centre of the circular container by the front and rear edges of the inner dye drop.

[0080] FIG. 9 is a perspective view of an apparatus of FIG. 5 during measurement of centric-shear banding showing an inner annular region of high shear relatively rapidly flowing liquid, a torroidal region (outboard of the annular region) in which the shear and flow is significantly reduced and the interface between the two regions.

[0081] FIG. 10 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a first glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B2.

[0082] FIG. 11 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a second glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B2.

[0083] FIG. 12 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a third glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B2.

[0084] FIG. 13 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a second glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B3.

[0085] FIG. 14 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a third glycaemic test profile of a drink and powder composition not in accordance with the invention with a control in accordance with Example B3.

[0086] FIG. 15 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a first glycaemic test profile of a drink and powder composition not in accordance with the invention with a control in accordance with Example B4.

[0087] FIG. 16 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a second glycaemic test profile of a drink and powder composition not in accordance with the invention with a control in accordance with Example B4.

[0088] FIG. 17 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a first glycaemic test profile of a drink and powder composition not in accordance with the invention with a control in accordance with Example B5.

[0089] FIG. 18 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a second glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B5.

[0090] FIG. 19 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a first glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B6.

[0091] FIG. 20 is a graph comparing the variation in glycaemic profile (mM blood glucose) with time (minutes) comparing a first glycaemic test profile of a drink and powder composition in accordance with the invention with a control in accordance with Example B7.

ECCENTRIC SHEAR-BANDING PROTOCOL: OBJECTIVE MEASUREMENT OF ECCENTRIC SHEAR-BANDING IN A DRINK

[0092] Referring to FIGS. 1 to 4 a quantity of test drink (1) containing 150 mls of water (e.g. 175 total drink weight g) is well stirred and poured into a circular flat-bottomed container (2) with a base (3) and cylindrical wall (4). The container has a diameter of 90 mm and a wall (4) height of 50 mm. The height of the surface (5) drink (1) in the container (2) is 25 mm. A drop of dye (6) is placed on a reference radius (8) at a point 20 mm in from the wall (4) of the container on a notional line on the surface of the drink through the centre (7) of the circular container (4). This drop of dye (6) will be used to define angle A as described below to determine whether eccentric shear-banding is exhibited by the sample. A smooth wooden cylinder (9) of diameter 12 mm is mounted in a rotatable chuck (10) with the axis of the cylinder (9) vertical, and the flat base (11) of the cylinder (9) is located above the drink surface. The cylinder (9) is rotated at 850 rpm.

[0093] The driven-flow aspect of the measurement is initiated by lowering the rotating cylinder (9) into the drink at a distance (9a) 15 mm from the cylindrical wall (4) of the container (2) and at an angle about the centre of the container of 225 (8a) from the reference radius (8) and position of the dye marker (6). The bottom of the cylinder (11) is lowered to a depth (13) of 20 mm below the drink surface (5). After 90 seconds, the rotation of the cylinder (9) is arrested, and the cylinder (9) is slowly withdrawn from the drink.

[0094] Quantitative Definition of Eccentric Shear-Banding in Terms of Angle A

[0095] After driving the drink (1) in the container (2) by lowering the rotating cylinder (9) for 90 seconds the dye droplet (6) is inspected. The resulting droplet may be highly elongated with a front edge and a trailing edge in which the leading edge of inner dye mark (6) has become highly elongated extending through multiple revolutions about the centre (7). Alternatively the droplet may have relatively minor elongation (so that the angle subtended at the centre of the circular container is small). The angle subtended at the centre of the circular container by the front (16) and a rear edge (17) of the drop is designated angle A (see FIG. 4). If angle A is less than 40 then the liquid is considered to exhibit shear-banding behaviour. The angle A (see FIG. 4) may be measured by protractor or other suitable angle measurement apparatus.

[0096] Protocol for Determination of Eccentric Shear-Banding Interface Distances

[0097] The eccentric shear-banding test provides an annular band region of flow driven by the eccentric rotating cylinder. Compositions of the invention when subject to the above described eccentric shear-banding test, exhibit distinct bands or regions including an inner band or region about the rotating cylinder of relatively high shear (26) and rapid flow and an outer band (27) which does not exhibit significant shear and which is substantially static when compared with the inner high shear rapid flow region adjacent the rotating cylinder. In compositions of the invention the outer band or torroid region which does not exhibit significant shear and which is substantially static will include the dye drop and produce the eccentric shear-banding result as hereinbefore defined (that Angle A is less than 40).

[0098] The interface between the two regions (25) can be readily determined by visual inspection while the cylinder is being driven during the test period. The distance (28) of the interface (25) from the rotating cylinder (9) can also be determined during this period using a ruler.

[0099] Eccentric Shear-Banding Testing of Drinks Prepared from Mixing a Powder with Aqueous Liquid

[0100] Many drinks made from reconstituted drink powder have time-variant flow characteristics. For such drinks, the following standard time sequence should be used to implement the above process. Step 1reconstitute the drink in 150 mls of water and allow the reconstituted drink to rest for 7 minutes. Step 2stir the rested drink and pour the drink into the above-described circular flat-bottomed container (2). After 2 minutes apply the dye drops (6) described above to the surface (5) of the drink (1), and lower the rotating cylinder (9) into the drink (1) approx. 15 mm from the container wall as described above.

[0101] The above protocol always leads to the formation of a layer of liquid that manifests local shear immediately proximal to the surface of the rotating cylinder.

[0102] In many driven drinks the shearing layer grows radially outwards from the surface of the rotating cylinder and extends throughout the liquid (although the tangential velocity of the driven drink will be significantly slower at positions further from the rotating cylinder and closer to the wall of the container). However, in drinks that exhibit eccentric shear band formation (i.e. drinks according to the current invention), a locally static layer of significant thickness (e.g. 3-20 mm or even more measured from the cylinder toward the centre of the container) develops further out from the cylinder, and this locally static outer layer coexists with the shearing inner layer. The term locally static layer means no shear or comparatively very little shear is exhibited within said layer. The simultaneous existence of an extensive shearing band and an extensive locally static band in a steady-state driven flow scenario is the characteristic feature of eccentric shear band formation.

[0103] In more general terms, eccentric shear band formation occurs in a driven-flow scenario when there is co-existence of (a) an extensive region of drink material that exhibits no local shear, and (b) an extensive region of drink material that exhibits significant local shear.

[0104] The above protocol provides a very sensitive test of eccentric\ shear band formation because an extensive shearing/rotating band is always found near the surface of the rotating cylinder, and because the shape of the red dye drop is very sensitive to the existence of local shear. Eccentric shear band formation can be detected in the above protocol whenever the liquid dye drop substantially maintains its starting shape (generally circular). In the presence of even small amounts of local shear, the liquid dye drop becomes significantly elongated in response to the local shear. This liquid-drop test for local shear is significantly more sensitive than can be achieved by introducing high-contrast solid particles to the drink (as flow markers)this is because a solid marker will move according to the resultant forces on the solid particle, and local shear can be inferred only by comparing one particle of solid marker with a separate particle of marker.

[0105] Shear Banding Protocol: Objective Measurement of Centric Shear Banding in a Drink

[0106] Referring to FIGS. 5 to 9 a quantity of test drink (1) containing 150 mls of water (e.g. 175 total drink weight g) is well stirred and poured into a circular flat-bottomed container (2) with a base (3) and cylindrical wall (4). The container has a diameter of 90 mm and a wall (4) height of 50 mm. The height of the surface (5) drink (1) in the container (2) is 25 mm. A drop of water-soluble dye (6a) is placed on the surface of the drink (5) close to the wall of the container (4) and a notional line on the surface of the drink from the centre (7) of the circular container and this mark (6a) is chosen as a reference diameter (8). Another drop of dye (6b) is placed on the reference diameter (8) at a point 20 mm in from the wall (4) of the container. This drop of dye (6b) will be used to define angle A as described below to determine whether shear banding is exhibited by the sample. A smooth wooden cylinder (9) of diameter 12 mm is mounted in a rotatable chuck (10) with the axis of the cylinder (9) vertical, and the flat base of the cylinder (9) is located above the drink surface in such a way that the (vertical) axis (12) of the cylinder (9) is coincident with the (vertical) axis (12) of the circular flat-bottomed container (2). The cylinder (9) is rotated at 850 rpm.

[0107] The driven-flow aspect of the measurement is initiated by lowering the rotating cylinder (9) into the drink to a depth (13) of 20 mm below the drink surface (5). After 90 seconds, the rotation of the cylinder (9) is arrested, and the cylinder (9) is slowly withdrawn from the drink.

[0108] Quantitative Definition of Shear Banding in Terms of Angle A

[0109] After driving the drink (1) in the container (2) by lowering the rotating cylinder (9) for 90 seconds the inner dye droplet (6b) is inspected. The resulting droplet may be highly elongated with a front edge and a trailing edge becoming highly elongated and extending through multiple revolutions about the centre as is evident from the band width of dye. Alternatively the droplet may have relatively minor elongation (so that the angle subtended at the centre of the circular container is small (see FIG. 8). The angle (A) subtended at the centre of the circular container by the front (14) and a rear edge (15) of the drop is designated angle A (see FIG. 8). If angle A is less than 40 C. then the liquid is considered to exhibit shear-banding behaviour. The angle A (see FIG. 8) may be measured by protractor or other suitable angle measurement apparatus.

[0110] Protocol for Determination of Shear Banding Interface Distances

[0111] The shear banding test provides an annular band region of flow driven by the central rotating cylinder. Compositions of the invention when subject to the above described shear banding test, exhibit distinct band or regions including an inner band or region about the rotating cylinder of relatively high shear and rapid flow and an outer band or torroid region adjacent the wall of the container in which the shear and flow is significantly reduced when compared with the inner high shear rapid flow region adjacent the rotating cylinder. In compositions of the invention the outer band or torroid region of relatively low shear and reduced flow will include the dye drop and produce the shear banding result as hereinbefore defined.

[0112] The interface between the two regions can be readily determined by visual inspection while conducting the test and the distance of the interface from the rotating cylinder determined.

[0113] The interface between inner band or region of relatively rapid flow and the outer band or torroid region of low shear and reduced flow will be described with reference to FIG. 5.

[0114] Referring to FIG. 9 the interface (25) between inner rapid flow region (26) adjacent the rotating cylinder (9) and the outer torroid region (which has a shear flow sufficiently low to produce a shear banding result) is visually evident to the naked eye and the distance (28) of the interface (25) from the rotating cylinder may be measured using a ruler placed adjacent the side of the rotating cylinder (9).

[0115] We have found that compositions which are most efficacious in moderating blood glucose levels have an annular interface spaced from the rotating cylinder by at least 2.5 mm, preferably at least 5 mm, more preferably at least 7 mm, such as at least 10 mm or at least 12 mm.

[0116] The interface will be at least 10 mm inside of the diameter at which the dye drop is placed (20 mm in from the wall). The interface is preferably no more than 18 mm from the rotating cylinder and more preferably no more than 16 mm. Accordingly, the interface will typically fall in a distance of from 2.5 mm to 18 mm from the rotating cylinder, more preferably 5 mm to 16 mm, still more preferably 7 mm to 16 mm such as 70 mm to 16 mm or from 12 mm to 16 mm.

[0117] Shear Banding Testing of Drinks Prepared from Mixing a Powder with Aqueous Liquid

[0118] Many drinks made from reconstituted drink powder have time-variant flow characteristics. For such drinks, the following standard time sequence should be used to implement the above process. Step 1reconstitute the drink in 150 mls of water and allow the reconstituted drink to rest for 7 minutes. Step 2stir the rested drink and pour the drink into the above-descried circular flat-bottomed container (2). After 2 minutes apply the dye drops (6a, 6b) described above to the surface (5) of the drink (1), and lower the rotating cylinder (9) into the drink (1).

[0119] The above protocol always leads to the formation of a layer of liquid that manifests local shear immediately proximal to the surface of the rotating cylinder.

[0120] In many driven drinks the shearing layer grows radially outwards from the surface of the rotating cylinder and extends throughout the liquid (although the tangential velocity of the driven drink will be significantly slower at positions further from the rotating cylinder and closer to the wall of the container). However, in drinks that exhibit shear band formation (i.e. drinks according to the current invention), a locally static layer (adjacent the wall) of significant thickness (e.g. 15-20 mm or even more) develops further out from the cylinder, and this locally static outer layer coexists with the shearing inner layer. The term locally static layer means no shear is exhibited within said layer. The simultaneous existence of an extensive shearing band and an extensive locally static band in a steady-state driven flow scenario is the characteristic feature of shear band formation.

[0121] In more general terms, shear band formation occurs in a driven-flow scenario when there is co-existence of (a) an extensive region of drink material that exhibits no local shear, and (b) an extensive region of drink material that exhibits significant local shear.

[0122] The above protocol provides a very sensitive test of shear band formation because an extensive shearing/rotating band is always found near the surface of the rotating cylinder, and because the shape of the red dye drop is very sensitive to the existence of local shear. Shear band formation can be detected in the above protocol whenever the liquid dye drop substantially maintains its starting shape (generally circular). In the presence of even small amounts of local shear, the liquid dye drop becomes significantly elongated in response to the local shear. This liquid-drop test for local shear is significantly more sensitive than can be achieved by introducing high-contrast solid particles to the drink (as flow markers)this is because a solid marker will move according to the resultant of all forces on the solid, and local shear can be inferred only by comparing one particle of solid marker with a separate particle of marker.

Example A1

[0123] Single-Serve (Unit Dose) Powder Sample with 25 mg Acarbose (this Sample is Prepared According to the Method of the Invention).

[0124] 25 mg acarbose (half a 50 mg acarbose pharmaceutical tablet) was placed into a mortar and ground to a fine powder with a pestle. 1 g whey powder was added to the mortar with further grinding to provide a finely ground powder composite of acarbose and whey powder. This powder composite was quantitatively added to a larger powder composition comprising: (i) 20 g whey powder concentrate, and (ii) 5 g guar gum powder. The total sample was added to a plastic bag, a knot was tied at the top of the bag, and further mixing took place by shaking the bag and its contents for 2 minutes. A pre-meal drink based on this powder sample was made and used by (i) adding 150 mls water to a graduated shaking vessel, (ii) quantitatively adding the single-serve powder sample described above, (iii) capping the shaking vessel with a screw cap containing a stopper, and shaking vigorously for 5 seconds, then (iv) removing the stopper and quickly consuming the entire liquid contents of the shaker vessel.

Example A1a

[0125] Single-Serve Powder Sample (No Acarbose) (this Sample is for a Pre-Meal Drink but Lacks Therapeutic Agentit is not Prepared According to the Method of the Invention)

[0126] This powder sample comprised: (i) 20 g whey powder concentrate, and (ii) 5 g guar gum powder. The total sample was added to a plastic bag, a knot was tied at the top of the bag, and further mixing took place by shaking the bag and its contents for 2 minutes. A pre-meal drink based on this powder sample was made using the procedure described in example A1 above.

Example A1b

[0127] Single-Serve Powder Sample with 12.5 mg Acarbose (this Sample is Prepared According to the Method of the Invention).

[0128] 12.5 mg acarbose (a quarter of a 50 mg acarbose pharmaceutical tablet) was placed into a mortar and ground to a fine powder with a pestle. 1 g whey powder was added to the mortar with further grinding to provide a finely ground powder composite of acarbose and whey powder. This powder composite was quantitatively added to a larger powder composition comprising: (i) 20 g whey powder concentrate, and (ii) 5 g guar gum powder. The total sample was added to a plastic bag, a knot was tied at the top of the bag, and further mixing took place by shaking the bag and its contents for 2 minutes. A pre-meal drink based on this powder sample was made and used by (i) adding 150 mls water to a graduated shaking vessel, (ii) quantitatively adding the single-serve powder sample described above, (iii) capping the shaking vessel with a screw cap containing a stopper, and shaking vigorously for 5 seconds, then (iv) removing the stopper and quickly consuming the entire liquid contents of the shaker vessel.

Example A1c

[0129] Single-Serve Powder Sample with 25 mg Acarbose (this Sample is Prepared According to the Method of the Invention).

[0130] 25 mg acarbose (a half of a 50 mg acarbose pharmaceutical tablet) was placed into a mortar and ground to a fine powder with a pestle. 1 g whey powder was added to the mortar with further grinding to provide a finely ground powder composite of acarbose and whey powder. This powder composite was quantitatively added to a larger powder composition comprising: (i) 20 g whey powder concentrate, and (ii) 5 g psyllium husk. The total sample was added to a plastic bag, a knot was tied at the top of the bag, and further mixing took place by shaking the bag and its contents for 2 minutes. A pre-meal drink based on this powder sample was made and used by (i) adding 150 mls water to a graduated shaking vessel, (ii) quantitatively adding the single-serve powder sample described above, (iii) capping the shaking vessel with a screw cap containing a stopper, and shaking vigorously for 5 seconds, then (iv) removing the stopper and quickly consuming the entire liquid contents of the shaker vessel.

Example A1d

[0131] Single-Serve Powder Sample with 25 mg Acarbose.

[0132] 25 mg acarbose (a half of a 50 mg acarbose pharmaceutical tablet) was placed into a mortar and ground to a fine powder with a pestle. 1 g whey powder was added to the mortar with further grinding to provide a finely ground powder composite of acarbose and whey powder. This powder composite was quantitatively added to a larger powder composition comprising: (i) 25 g whey protein concentrate. The total sample was added to a plastic bag, a knot was tied at the top of the bag, and further mixing took place by shaking the bag and its contents for 2 minutes. A pre-meal drink based on this powder sample was made and used by (i) adding 150 mls water to a graduated shaking vessel, (ii) quantitatively adding the single-serve powder sample described above, (iii) capping the shaking vessel with a screw cap containing a stopper, and shaking vigorously for 5 seconds, then (iv) removing the stopper and quickly consuming the entire liquid contents of the shaker vessel.

Example A1e

[0133] Single-Serve Powder Sample with 25 mg Acarbose.

[0134] 25 mg acarbose (a half of a 50 mg acarbose pharmaceutical tablet) was placed into a mortar and ground to a fine powder with a pestle. 1 g whey powder was added to the mortar with further grinding to provide a finely ground powder composite of acarbose and whey powder. This powder composite was quantitatively added to a larger powder composition comprising: (i) 12.5 g milk protein isolate powder and (ii) 10.17 g whey protein concentrate powder and (iii) 0.325 g guar gum and (iv) 0.125 g xanthan gum. The total sample was added to a plastic bag, a knot was tied at the top of the bag, and further mixing took place by shaking the bag and its contents for 2 minutes. A pre-meal drink based on this powder sample was made and used by (i) adding 150 mls water to a graduated shaking vessel, (ii) quantitatively adding the single-serve powder sample described above, (iii) capping the shaking vessel with a screw cap containing a stopper, and shaking vigorously for 5 seconds, then (iv) removing the stopper and quickly consuming the entire liquid contents of the shaker vessel.

Example A2

[0135] Standard White Rice Meal

[0136] 160 g microwaveable white rice (details, amount of available carbohydrate?) was eaten together with a cup of water.

Example A3

[0137] Standard White Rice Meal No. 2

[0138] 125 g microwaveable white rice (details, amount of available carbohydrate?) was eaten together with a cup of water.

Example A3a

[0139] Standard white rice meal No. 3

[0140] 240 g microwaveable white rice (Uncle Bens Brand Microwavable White Rice, 182.4 g of available carbohydrate) and 200 ml of hot tea.

Example A4

[0141] Standard White Bread Meal

[0142] 2 slices of thick-cut savoury white bread spread with 29 g jam (over both slices) were eaten together with a cup of tea or coffee. A total available carbohydrate per serve was 50 g.

Example A4a

[0143] Standard White Bread Meal No. 2,

[0144] 2 slices of thick-cut savoury white bread spread with 29 g jam (over both slices) were eaten together with a cup of tea or coffee. 25 mg acarbose consumed with first mouthful of meal. A total available carbohydrate per serve was 50 g.

Example A5

[0145] Protocol to Measure Post-Prandial Glycemic Profile

[0146] Finger-prick blood sugar readings were taken before consumption of the standard meal in the morning (i.e. the standard meal was breakfast). Two readings were taken and the average value was used as the blood sugar reading. After consumption of the meal, another blood sugar reading was taken. Further blood sugar readings were taken at 15-minute intervals thereafter.

Example B1

[0147] A subject (HP2, Healthy Participant, Male, Age 30,) was given a standard white rice breakfast, containing 125 g cooked white rice (example A3), and was tested for post-prandial glycemic profilethis was the first control glycemic profile. On another day, the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white rice breakfastthis was the second control glycemic profile. On another day, the same subject was given the pre-meal drink, which did not contain acarbose (see example A1a abovethis pre-meal drink was consumed immediately before the meal). This was the third control glycemic profile. On another day, the same subject was given the acarbose-containing pre-meal drink described in example A1 (this drink is prepared according to the invention). This was the test glycemicsrofile.

[0148] Healthy Participant Protocol [0149] 1) 125 g of white rice [0150] 2) 25 mg of Acarbose with 125 g of white rice [0151] 3) Premeal drink immediately prior to 125 g of white rice [0152] 4) 25 mg of Acarbose mixed into premeal drink, consumed immediately prior to 125 g of white rice.

TABLE-US-00001 TABLE 1 AB - HP2 Test First Second Third glycemic control control control profile Time glycemic glycemic glycemic (mM blood after profile profile profile glucose) as eating (mM blood (mM blood (mM blood according to (mins) glucose) glucose) glucose) the invention 15 5.05 5.65 5.53 5.6 0 5.83 6.03 5.75 5.7 15 7.5 6.4 6.3 6 30 8.03 7.04 7.2 5.75 45 7.35 6.75 6.3 5.95 60 7 5.9 5.75 6.25 75 6.65 6.1 5.55 5.75 90 5.9 6.175 6.05 5.75 105 6.15 5.8 6.46 5.83 120 6.25 6.3 5.8 6.05 135 5.9 6.23 5.55 150 5.83 6 165

[0153] A subject with type 2 diabetes (T2D1, Female, Age 62,) was given a standard white rice breakfast (Example A2) and was tested for post-prandial glycemic profilethis was the first control glycemic profile. On another day, the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white rice breakfastthis was the second control glycemic profile. On another day, the same subject was given the pre-meal drink which did not contain acarbose (see example A1a abovethis premeal drink was consumed immediately before the meal). This was the third control glycemic profile. On another day, the same subject was given the acarbose-containing pre-meal drink described in example A1 (this drink is prepared according to the invention). This was the test glycemic profile.

TABLE-US-00002 TABLE 2 AC T2D1 Test First Second Third glycemic control control control profile Time glycemic glycemic glycemic (mM blood after profile profile profile glucose) as eating (mM blood (mM blood (mM blood according to (mins) glucose) glucose) glucose) the invention 15 9.26 8.8 9.35 8.9 0 11.1 8.9 10.2 8.6 15 11.5 9.13 10.7 8.75 30 11.4 9 10.8 9 45 10.8 9.6 10.1 8.52 60 11.2 9.8 11 9 75 11.3 9.6 11.2 9.42 90 11.1 10.9 10.5 8.45 105 11.6 9.65 10.4 9.06 120 11.2 10.25 10.6 9.05 135 10.8 9.82 9.2 8.4 150 11 9.26 8.9 7.6 165 10.9 9.05 8.7 7.9

[0154] A subject with type 2 diabetes (T2D3, Female, Age 65,) was given a standard white rice breakfast (Example A2) and was tested for post-prandial glycemic profilethis was the first control glycemic profile. On another day, the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white rice breakfastthis was the second control glycemic profile. On another day, the same subject was given the pre-meal drink which did not contain acarbose (see example A1a abovethis premeal drink was consumed immediately before the meal). This was the third control glycemic profile. On another day, the same subject was given the acarbose-containing pre-meal drink described in example A1 (this drink is prepared according to the invention). This was the test glycemic profile.

TABLE-US-00003 TABLE 3 AD T2D3 Test First Second Third glycemic control control control profile Time glycemic glycemic glycemic (mM blood after profile profile profile glucose) as eating (mM blood (mM blood (mM blood according to (mins) glucose) glucose) glucose) the invention 15 8.45 7.96 0 11.1 9.13 15 13.0 10 30 12.6 9.5 45 12.4 10.4 60 11.8 10.1 75 10.7 9.15 90 9.9 8.25 105 8.9 7.75 120 9.16 6.7 135 9.1 6.35 150 9.05 6.2 165 7.9 5.8

[0155] A subject with type 2 diabetes (T2D5, Female, Age 65,) was given a standard white rice breakfast (Example A2) and was tested for post-prandial glycemic profilethis was the first control glycemic profile. On another day, the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white rice breakfastthis was the second control glycemic profile. On another day, the same subject was given the pre-meal drink which did not contain acarbose (see example A1a abovethis premeal drink was consumed immediately before the meal). This was the third control glycemic profile. On another day, the same subject was given the acarbose-containing pre-meal drink described in example A1 (this drink is prepared according to the invention). This was the test glycemic profile.

TABLE-US-00004 TABLE 4 AD T2D5 Test First Second Third glycemic control control control profile Time glycemic glycemic glycemic (mM blood after profile profile profile glucose) as eating (mM blood (mM blood (mM blood according to (mins) glucose) glucose) glucose) the invention 15 6.25 5.96 0 8 5.75 15 8.7 5.7 30 8.75 5.9 45 6.86 5.3 60 6.23 5.75 75 5.8 5.65 90 5.55 5.75 105 5.86 5.55 120 5.75 6.05 135 5.95 6 150 6.1 5.5 165 5.95 5.35

[0156] The test glycemic profile (obtained using the method of the invention) was consistently lower than any of the 3 control profiles

[0157] It was noticed that when a 50 mg tablet of acarbose was taken with, or soon before or soon after the consumption of a pre-meal drink not containing acarbose, the resultant glycemic profile was significantly higher than if said tablet was taken together with the standard meal (i.e. the profile was higher than the second control glycemic profile in table AA). So the method of the invention provides for a better post-prandial glycemic profile than if the acarbose was delivered in tablet form alongside the pre-meal drink.

Example B2

[0158] A subject with type 2 diabetes (T2D5, Female, Age 65,) was given a standard white rice breakfast, containing 240 g cooked white rice (example A3a) and also the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white rice breakfast and was tested for post-prandial glycemic profilethis was the glycemic control profile. On another day, the same subject was given a pre-meal drink containing 12.5 mg acarbose, 20gWPC80, 5 g guar gum and 150 ml of water (see example A1b this premeal drink was consumed immediately before the meal)this was the first glycemic test profile. On another day, the same subject was given a pre-meal drink, which contained 25 mg acarbose, 20 g whey protein and 5 g psyllium husk (see example A1c abovethis pre-meal drink was consumed immediately before the meal). This was the second glycemic test profile. On another day the same subject was given a pre-meal drink containing 25 mg acarbose, 20gWPC80, 5 g guar gum and 150 ml of water (see example A1)This was the third glycemic test profile.

[0159] Summary of Protocols

[0160] Control

[0161] 25 mg of acarbose with 240 g of white rice

[0162] First Glycemic Test

[0163] 12.5 mg acarbose mixed with premeal (20gWPC80+5 g guar gum) drink (made according to the method of the invention) (see example A1b) immediately before 240 g of white rice

[0164] 2.sup.nd Glycemic Test

[0165] 25 mg of Acarbose mixed into a premeal drink (20gWPC80, 5 g Psyllium husk) (made according to the method of the invention) (see example A1c), consumed immediately prior to 240 g of white rice.

[0166] 3.sup.rd Glycemic Test

[0167] 25 mg of Acarbose mixed into premeal drink (20 g WPC80, 5 g guar gum) (made according to the method of the invention) (see example A1a), consumed immediately prior to 240 g of white rice.

TABLE-US-00005 TABLE 5 T2D5 First Second Third Glycemic glycemic glycemic glycemic Time control test test test after profile profile profile profile eating (mM blood (mM blood (mM blood (mM blood (mins) glucose) glucose) glucose) glucose) 25 5 5.7 5 7.13 10 5.2 6.15 5.5 7.42 0 7.4 6.55 6.35 8.46 15 8.8 8.1 7.35 8.97 30 10.4 9.85 8.2 9.5 45 10.1 8.7 9.16 9.85 60 9.7 8.6 9.75 9.83 75 9.95 7.7 10.2 9.9 90 9.2 7.5 9.55 9.35 105 8.7 6.9 8.93 9.4 120 8.73 7.15 7.35 8.2 135 8.53 6.93 6.56 7.3 150 8.56 6.65 5.95 7.25 165 7.3 6.2 5.65 6.5 180 6.5 5.65 5.35 5.85

[0168] The results of the first glycaemic test profile are plotted together with the control in FIG. 10.

[0169] When participant T2D5 consumed a premeal drink containing 12.5 mg of Acarbose, 20 g whey protein and 5 g guar gum (see example A1amade according to the method of the invention) immediately prior to 240 g of white rice:

[0170] Participant produced a better glycemic profile when compared to control [0171] lower post prandial glucose levels from t=30 minutes to t=180 minutes compared to control.

[0172] The results of the second glycaemic test profile are plotted againse the control profile in FIG. 11.

[0173] When participant T2D5 consumed a premeal drink containing 25 mg of Acarbose, 20 g whey protein and 5 g psyllium husk (see example A1amade according to the method of the invention) immediately prior to 240 g of white rice:

[0174] Participant produced a better glycemic profile when compared to control [0175] Produced lower glucose levels from t=0 minutes to t=60 minutes and from t=120 minutes to t=180 minutes compared to control.

[0176] The results of the third glycaemic test profile and control profile are plotted in FIG. 12.

[0177] When participant T2D5 consumed a premeal drink containing 25 mg of Acarbose, 20 g whey protein and 5 g guar gum (see example A1amade according to the method of the invention) immediately prior to 240 g of white rice:

[0178] Participant produced a better glycemic profile when compared to control [0179] Lower post prandial peak than control. If baselines of both profiles are matched, peak glucose height when taking the premeal (containing 25 mg acarbose whey protein and guar gummade according to the method of the invention) produces a 2.85 mmol/L rise above baseline. Compared against the control showing a raise above baseline of 5.3 mmol/L. [0180] If baselines of both profiles were matched, the glucose profile relating to the premeal containing 25 mg acarbose whey protein and guar gum (made according to the method of the invention) would be considered lower than control for the entirety of the testing time.

Example B3

[0181] A subject with type 2 diabetes (T2D1, Female, Age 62,) was given a standard white rice breakfast, containing 240 g cooked white rice (example A3a), and also the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white rice breakfast and was tested for post-prandial glycemic profilethis was the control glycemic profile. On another day, the same subject was given a pre-meal drink, which contained 25 mg acarbose, 20 g whey protein and 5 g psyllium husk (see example A1c abovemade according to the method of the invention). This was the second test glycemic profile. On another day the same subject was given a pre-meal drink containing 25 mg acarbose, 20gWPC80, 5 g guar gum and 150 ml of water (see example A1made according to the method of the invention)This was the third test glycemic_profile.

[0182] Person with type 2 diabetes protocol

[0183] Control25 mg of acarbose with 240 g of white rice

[0184] 1.sup.st Glycemic TestNot Done

[0185] 2.sup.nd Glycemic Test25 mg of Acarbose mixed into premeal drink (20 g WPC80, 5 g psyllium huskmade according to the method of the invention) (see example A1c), consumed immediately prior to 240 g of white rice.

[0186] 3.sup.rd Glycemic Test25 mg of Acarbose mixed into premeal drink (20gWPC80, 5 g guar gummade according to the method of the invention) (see example A1a), consumed immediately prior to 240 g of white rice.

TABLE-US-00006 TABLE 6 T2D1 First Second Third glycemic glycemic glycemic Time Control test test test after profile profile profile profile eating (mM blood (mM blood (mM blood (mM blood (mins) glucose) glucose) glucose) glucose) 25 7.3 7.4 7.55 10 7.85 7.7 7.96 0 8.95 8.33 9.2 15 9.2 9.28 10.2 30 9.32 9.45 8.85 45 8.7 9.7 9.45 60 10.4 10.2 9.05 75 11.0 11.0 9.06 90 10.8 10.4 9.9 105 11 9.06 8.8 120 10.4 8.73 8.3 135 10.4 8.55 8.8 150 8.65 7.63 8.4 165 9.45 8.2 7.1 180 9.66 7.36 7.95

[0187] The results of the second glycaemic test profile are plotted against the control in FIG. 13.

[0188] When participant T2D1 consumed a premeal drink containing 25 mg of Acarbose, 20 g whey protein and 5 g psyllium husk (see example A1cmade according to the method of the invention) immediately prior to 240 g of white rice:

[0189] Participant produced a better glycemic profile when compared to control [0190] lower post-prandial glucose levels from t=105 minutes to t=180 minutes compared to control.

[0191] The results of the third glycaemic test profile are plotted against the control in FIG. 14

[0192] When participant T2D1 consumed a premeal drink containing 25 mg of Acarbose, 20 whey protein and 5 g guar gum (see example A1amade according to the method of the invention) immediately prior to 240 g of white rice:

[0193] Participant produced a better glycemic profile when compared to control [0194] lower peak glucose height compared to control (0.85 mmol/L lower than control) [0195] blood glucose stayed lower for longer (from t=60 minutes to t=150 minutes) compared to control

Example B4

[0196] A subject with type 2 diabetes (T2D5, Female, Age 65,) was given a standard white bread breakfast, containing 2 slices of white bread+29 g Jam (example A4) and also the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white bread breakfast and was tested for post-prandial glycemic profilethis was glycemic control profile. On another day, the same subject was given a pre-meal drink (not according to the invention), which contained 25 mg acarbose and 25 g whey protein (see example A1d abovethis pre-meal drink was consumed 15 minutes before the meal). This was the first glycemic test profile. On another day, the same subject was given a pre-meal drink (not according to the invention), which contained 25 mg acarbose and 12.5 g milk protein isolate and 10.17 g whey protein and 0.325 g guar gum and 0.125 g xanthan gum (see example A1e abovethis pre-meal drink was consumed immediately before the meal). This was the second glycemic test profile.

[0197] Control25 mg of acarbose with first mouthful of 2 slices of white bread+29 g Jam (see example A4a)

[0198] 1.sup.st Glycemic Test25 mg of Acarbose mixed into a premeal drink (not according to the invention) containing 25 g whey protein, (see example A1d) consumed 15 minutes prior to 2 slices of white bread+29 g Jam.

[0199] 2.sup.nd Glycemic Test25 mg of Acarbose mixed into a premeal drink (not according to the invention) containing 10.17 g whey protein and 12.5 g milk protein isolate and 0.325 g guar gum and 0.125 g xanthan gum, (see example A1e) consumed immediately prior to 2 slices of white bread+29 g Jam.

TABLE-US-00007 TABLE 7 Participant T2D5 First Second Glycemic glycemic glycemic Time control test test after profile profile profile eating (mM blood (mM blood (mM blood (mins) glucose) glucose) glucose) 25 6.25 5.55 6.93 10 6.5 5.65 6.9 0 8.5 6.7 7.56 15 9.3 7.6 8.33 30 9.5 8.4 8.37 45 9.65 8.4 8.35 60 9.85 8.9 9.1 75 9.6 9.7 10.2 90 9.8 9.2 11.0 105 9.35 9.95 11.5 120 9.05 11.9 10.4 135 7.65 10.4 9.45 150 6.93 9.65 8.4 165 6.55 8.6 7.2 180 5.35 6.8 6.85

[0200] The results of the first test profile are plotted with the control profile in FIG. 15.

[0201] When participant T2D5 consumed a premeal drink containing 25 mg of Acarbose and 25 g whey protein, (see example A1dnot according to the invention) 15 minutes prior to consuming 2 slices of white bread+29 g Jam.

[0202] Participant produced a worse glycemic profile when compared to control [0203] T2D5 produced 2.0 mmol higher post prandial peak height at t=120 minutes when compared against control.

[0204] The results of the second test profile are plotted with the control in FIG. 16.

[0205] When participant T2D5 consumed a premeal drink containing 25 mg of Acarbose 10.17 g whey protein and 12.5 g milk protein isolate and 0.325 g guar gum and 0.125 g xanthan gum, (see example A1enot according to the invention) immediately prior to consuming 2 slices of white bread+29 g Jam

[0206] Participant produced a worse glycemic profile when compared to control [0207] T2D5 produced 2.0 mmol higher post prandial peak height at t=105 min compared against control.

Example B5

[0208] A subject with type 2 diabetes (T2D9, Female, Age 61,) was given a standard white bread breakfast, containing 2 slices of white bread+29 g Jam (example A4) and also the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white bread breakfast and was tested for post-prandial glycemic profilethis was the control glycemic profile. On another day, the same subject was given a pre-meal drink, which contained 25 mg acarbose and 25 g whey protein (see example A1d abovethis pre-meal drink was consumed 15 minutes before the meal). This was the first test glycemic profile. On another day, the same subject was given a pre-meal drink, which contained 25 mg acarbose and 12.5 g milk protein isolate and 10.17 g whey protein and 0.325 g guar gum and 0.125 g xanthan gum (see example A1e abovethis pre-meal drink was consumed immediately before the meal). This was the second glycemic test profile.

[0209] Control25 mg of acarbose with first mouthful of 2 slices of white bread+29 g Jam (see example A4a).

[0210] 1.sup.st Glycemic Test25 mg of Acarbose mixed into a premeal drink (not according to the invention) containing 25 g whey protein, (see example A1d) consumed 15 minutes prior to 2 slices of white bread+29 g Jam.

[0211] 2.sup.nd Glycemic Test25 mg of Acarbose mixed into a premeal drink (not according to the invention) containing 10.17 g whey protein and 12.5 g milk protein isolate and 0.325 g guar gum and 0.125 g xanthan gum, (see example A1e) consumed immediately prior to 2 slices of white bread+29 g Jam.

TABLE-US-00008 TABLE 8 First Second Glycemic glycemic glycemic Time control control control after profile profile profile eating (mM blood (mM blood (mM blood (mins) glucose) glucose) glucose) 25 10.4 9.3 8.7 10 9.9 9.55 8.86 0 11.8 9.15 10.3 15 12.8 8.55 10.8 30 11.6 9.6 12.5 45 11.3 12.1 13.1 60 11.4 12.2 13.5 75 11.1 13 14.1 90 10.4 12.9 14.2 105 11.0 12 14.3 120 11.8 12.8 12.1 135 11.2 12.4 11.7 150 11.8 11.7 11.5 165 12.9 10.3 10.1 180 10.2 9.76 9.9

[0212] The results of the first test profile and control are plotted in FIG. 17.

[0213] When participant T2D9 consumed a premeal drink containing 25 mg of Acarbose and 25 g whey protein, (see example A1dnot according to the invention) 15 minutes prior to consuming 2 slices of white bread+29 g Jam.

[0214] Participant produced a worse glycemic profile when compared to control [0215] Equivalent peak height compared to control [0216] Blood glucose stayed much higher for longer when compared to control (from t=30 minutes to t=135 minutes)

[0217] The results of the second test profile and control are plotted in FIG. 18.

[0218] When participant T2D9 consumed a premeal drink containing 25 mg of Acarbose 10.17 g whey protein and 12.5 g milk protein isolate and 0.325 g guar gum and 0.125 g xanthan gum, (see example A1enot according to the invention) immediately prior to consuming 2 slices of white bread+29 g Jam

[0219] Participant produced a worse glycemic profile when compared to control [0220] 1.2 mmol higher post prandial peak height at t=105 min [0221] blood glucose stayed higher for longer when compared to control (from t=30 minutes to t=135 minutes) than control

Example B6

[0222] A subject with type 2 diabetes (T2D5, Female, Age 65,) was given a standard white rice breakfast, containing 240 g cooked white rice (example A3a) and also the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white bread breakfast and was tested for post-prandial glycemic profilethis was the control glycemic profile. On another day, the same subject was given a pre-meal drink, which contained 25 mg acarbose and 12.5 g milk protein isolate and 10.17 g whey protein and 1.475 g guar gum and 0.125 g xanthan gum (see example A1f abovethis pre-meal drink was consumed immediately before the meal). This was the first glycemic test profile.

[0223] Control25 mg of acarbose with first mouthful of 240 g cooked white rice (see example A3a)

[0224] 1st Glycemic Test25 mg of Acarbose mixed into a premeal drink (according to the invention) containing 10.17 g whey protein and 12.5 g milk protein isolate and 1.475 g guar gum and 0.125 g xanthan gum, (see example A1f) consumed immediately prior to 240 g cooked white rice.

TABLE-US-00009 TABLE 9 Time after Glycemic First glycemic eating control profile test profile (mins) (mM blood glucose) (mM blood glucose) 25 5 5.5 10 5.2 6.8 0 7.4 7.15 15 8.8 7.45 30 10.4 7.35 45 10.15 7.7 60 9.76 8.75 75 9.95 8.8 90 9.2 8.75 105 8.7 7.65 120 8.73 7.66 135 8.53 7.1 150 8.56 6.6 165 7.3 6.2 180 6.5 5.5

[0225] The results of the first test profile and control are plotted in FIG. 19.

[0226] When participant T2D5 consumed a premeal drink containing 25 mg of Acarbose 10.17 g whey protein and 12.5 g milk protein isolate and 1.475 g guar gum and 0.125 g xanthan gum, (see example A1faccording to the invention) immediately prior to consuming 240 g Cooked white rice.

[0227] Participant produced a better glycemic profile when compared to control [0228] lower post prandial peak height at t=75 min compared to control [0229] blood glucose stayed lower for longer when compared to control (from t=0 minutes to t=180 minutes)

Example B7

[0230] A subject with type 2 diabetes (T2D1, Female, Age 62,) was given a standard white rice breakfast, containing 240 g cooked white rice (example A3a) and also the same subject was given a tablet containing 25 mg of acarbose with the first bite of the standard white bread breakfast and was tested for post-prandial glycemic profilethis was the control glycemic profile. On another day, the same subject was given a pre-meal drink, which contained 25 mg acarbose and 12.5 g milk protein isolate and 10.17 g whey protein and 1.475 g guar gum and 0.125 g xanthan gum (see example A1f abovethis pre-meal drink was consumed immediately before the meal). This was the first glycemic test profile.

[0231] Control25 mg of acarbose with first mouthful of 240 g cooked white rice (see example A3a).

[0232] 1st Glycemic Test25 mg of Acarbose mixed into a premeal drink (according to the invention) containing 10.17 g whey protein and 12.5 g milk protein isolate and 1.475 g guar gum and 0.125 g xanthan gum, (see example A1f) consumed immediately prior to 240 g cooked white rice.

TABLE-US-00010 TABLE 10 Time after Glycemic First glycemic eating control profile test profile (mins) (mM blood glucose) (mM blood glucose) 25 7.3 8.1 10 7.85 8.7 0 8.95 9.26 15 9.2 9.46 30 9.32 10.2 45 8.7 9.03 60 10.4 9.7 75 11.0 9.75 90 10.8 9.73 105 11 9.03 120 10.4 9.05 135 10.4 8 150 8.65 8.7 165 9.45 8.36 180 9.66 8.2

[0233] The results of the first test profile and control are plotted in FIG. 20.

[0234] When participant T2D1 consumed a premeal drink containing 25 mg of Acarbose 10.17 g whey protein and 12.5 g milk protein isolate and 1.475 g guar gum and 0.125 g xanthan gum, (see example A1faccording to the invention) immediately prior to consuming 240 g Cooked white rice.

[0235] Participant produced a better glycemic profile when compared to control [0236] lower post prandial peak height at t=30 min compared to control [0237] blood glucose stayed lower for longer when compared to control (from t=60 minutes to t=150 minutes) than control.

Example B8

[0238] Formulations were tested by reconstituting ingredients and testing their flow capabilities at 30 seconds after reconstitution.

[0239] If after 30 seconds from reconstitution the ingredients cannot be freely poured out of the vessel used to reconstitute them, they would be considered as unsatisfactory drinks.

[0240] This involved:

[0241] 1. mixing ingredients within a shake and take container (for 5 seconds)

[0242] 2. Allow ingredients to rest for 30 seconds

[0243] 3. Attempt to pour ingredients out of the container.

TABLE-US-00011 TABLE 11 FORMULATION FLOW AT 30 SECONDS 25 mg Acarbose + 20 g Pourable liquid, contents Formulation WPC80 Protein + 5 g can be emptied from con- is in accor- guar gum + 150 ml tainer at t = 30 seconds dance with water invention. 25 mg Acarbose + 12 g Pourable liquid, contents Formulation WPC80 Protein + 5 g can be emptied from con- is inside of guar gum + 150 ml tainer at t = 30 seconds patent claims. water 25 mg Acarbose + 12 g Pourable liquid, contents Formulation Milk Protein Isolate + can be emptied from con- is inside of 7 g psyllium husk + tainer at t = 30 seconds patent claims. 150 ml water 25 mg Acarbose + 8 g Pourable liquid, contents Formulation Milk Protein Isolate + can be emptied from con- is inside of 7 g psyllium husk + tainer at t = 30 seconds patent claims. 150 ml water 25 mg Acarbose + 20 g Pourable liquid, contents Formulation Milk Protein Isolate + can be emptied from con- is inside of 7 g psyllium husk + tainer at t = 30 seconds patent claims. 150 ml water 25 mg Acarbose + 5 g Too viscous, contents could Formulation Soy Protein + 9 g not be emptied from con- is not of the guar gum + 150 ml tainer at t = 30 seconds invention water 25 mg Acarbose + 7 g Too viscous, contents could Formulation Soy Protein + 9 g not be emptied from con- is outside of guar gum + 150 ml tainer at t = 30 seconds patent claims. water 25 mg Acarbose + 5 g Too viscous, contents could Formulation MPI + 9 g guar gum + not be emptied from con- is outside of 150 ml water tainer at t = 30 seconds patent claims. 25 mg Acarbose + 5 g Too viscous, contents could Formulation WPC80 + 5 g guar gum + not be emptied from con- is outside of 150 ml water tainer at t = 30 seconds patent claims.

Example B9

[0244] Formulations were further tested for shearbanding and eccentric shearbanding:

TABLE-US-00012 TABLE 12 Eccentric Shearbanding Shearbanding Formulation Yes/No Yes/No 25 mg Acarbose + 20 g Yes Yes Formulation WPC80 Protein + 5 g is in accor- guar gum + 150 ml dance with water invention. 25 mg Acarbose + 12 g Yes Yes Formulation WPC80 Protein + 5 g is in accor- guar gum + 150 ml dance with water invention. 25 mg Acarbose + 12 g Yes Yes Formulation Milk Protein Isolate + is in accor- 7 g psyllium husk + dance with 150 ml water invention. 25 mg Acarbose + 10 g Yes Yes Formulation WPC80 Protein + 2.5 g is in accor- guar gum + 75 ml dance with water invention. 25 mg Acarbose + 6 g Yes Yes Formulation WPC80 Protein + 2.5 g is in accor- guar gum + 75 ml dance with water invention. 25 mg Acarbose + 6 g Yes Yes Formulation Milk Protein Isolate + is in accor- 3.5 g psyllium husk + dance with 75 ml water invention. 25 mg Acarbose + 10.17 No No Formulation gWPC80 + 12.5 g MPI + is not of 0.325 g guar gum + the inven- 0.125 g xanthan gum tion. (combined 0.45 g sol- uble fibre content) + 150 ml water 25 mg Acarbose + 25 No No Formulation gWPC80 + 150 ml water is not of the inven- tion. 25 mg Acarbose + 5 g No No Formulation Milk Protein Isolate + is not of 5 g psyllium husk + the inven- 150 ml water tion. 25 mg Acarbose + 5 No No Formulation gWPC80 + 6.25 g MPI + is not of 0.15 g guar gum + the inven- 0.6 g xanthan gum tion. (combined 0.45 g sol- uble fibre content) + 75 ml water 25 mg Acarbose + 12.5 No No Formulation gWPC80 + 75 ml water is not of the inven- tion. 25 mg Acarbose + 2.5 g No No Formulation Milk Protein Isolate + is not of 2.5 g psyllium husk + the inven- 75 ml water tion.