Composition for Weight Reduction Comprising a Beverage and Beads

Abstract

Subject of the invention is a composition for oral administration comprising a beverage and beads distributed in the beverage, wherein the beads have an average diameter between 2 to 10 mm, comprise more than 50% (w/w) dietary fibres, and wherein the amount of beads in the composition is between 1 and 20 wt. %. The invention also relates to devices and uses of the composition for reducing the weight of an individual and/or preventing weight gain.

Claims

1. A composition for oral administration comprising a beverage and beads distributed in the beverage, wherein the beads have an average diameter between 2 to 10 mm, comprise more than 50% (w/w) dietary fibres and wherein the amount of beads in the composition is between 1 and 20 wt. %.

2. The composition of claim 1, wherein the dietary fibres are cellulose fibres or derivatives thereof.

3. The composition according to claim 1, wherein the dietary fibres are not fermentable in humans.

4. The composition according to claim 1, wherein the energy content of the beads is below 500 kJ/100 g.

5. The composition according to claim 1, wherein the beverage without the beads comprises less than 1% (w/w) carbohydrates.

6. The composition according to claim 1, wherein the beverage is green tea.

7. The composition according to claim 1, wherein the energy content of the composition is below 100 kJ/100 g.

8. The composition according to claim 1, wherein the beads comprise at least one plant extract and/or plant active agents.

9. The composition according to claim 1, wherein the beads comprise at least one additive.

10. The composition according to claim 1, wherein the beverage is green tea and wherein the beads comprise methylcellulose and/or hydroxypropyl methylcellulose and glycyrrhizin.

11. The composition according to claim 1, wherein the beads are round, and/or wherein the beads comprise a coating, and/or wherein the beads are water-repellent.

12. The composition according to claim 1, wherein the composition comprises less than 1% (w/w) sugars which are selected from monosaccharides and disaccharides.

13. A device for storing and/or for preparing the composition of claim 1, the device comprising a beverage and beads for distribution in the beverage, wherein the device comprises containers in which the beverage and the beads are maintained separately, wherein the beverage and the beads are defined as in claim 1, wherein the ratio of the beads and the beverage in the device is adapted such that the composition comprises between 1 and 20 wt. % beads when all the beads are mixed into the beverage.

14. A method for reducing the weight of an individual and/or for preventing weight gain of an individual, which comprises administering a composition according to claim 1 to the individual.

15. The method of claim 14, which comprises consumption by the individual of a total daily amount of 200 to 2000 ml of the composition and/or consumption once or twice a day.

16. A method which comprises providing separate beads and beverage then mixing the beads and beverage to prepare a composition for oral administration of claim 1.

17. The composition according to claim 8, wherein the plant is selected from Glycyrrhiza glabra, Citrus aurantium (synephrine), wild yam (Dioscorea villosa), Mentha aquatic, Centella asiatica, Gingko, fruits and vegetables.

18. The composition according to claim 9, wherein the additive is selected from sweeteners, food supplements, antiadherents, binders, coatings, colorants, disintegrants, flavours, glidants, lubricants, preservatives, sorbents and hydrophobic substances.

19. The composition according to claim 18, wherein the additive is selected from stevia and chromium polynicotinate.

20. The device according to claim 13, wherein the beverage and the beads are maintained in separate containers adjoining each other.

Description

[0053] Exemplified embodiments of the invention and aspects of the invention are shown in the figures.

[0054] FIG. 1 shows beads for use in the composition.

[0055] FIG. 2 shows a composition, in which beads are distributed in a beverage.

[0056] In FIG. 1, an advantageous and typical embodiment of the beads is shown. The beads have regular spherical size and average diameters of about 4 to 5 mm. This size is appropriate for taking up the beads whilst drinking or sucking up the beads with the beverage with a straw. The uniform and smooth surface is pleasant for the consumer.

[0057] In FIG. 2, an inventive composition with beads distributed in a beverage is shown. The beads are heavier than the beverage and accumulate on the bottom of the cup. However, the beads could also be construed to float in the beverage or on top of the beverage by adjusting the content accordingly, for example if the beads are porous. The accumulation on the ground of the beverage is advantageous for sucking with a straw.

[0058] The inventive composition solves the problem underlying the invention. In trials with individuals who consumed the composition over extended periods of time, a significant effect on weight loss was observed. Further, it was found on a physiological level that the composition has an epigenetic effect. Physiological markers were found to be affected which control and influence weight obesity. Specifically, it was found that administration of the composition regularly over a period of several weeks lowers the level of proneurotensin in the blood. Proneurotensin is a known biomarker for weight control. The level of neurotensin is significantly determined by animal fats and sugars. Thus, the reduced proneurotensin level in the blood provides evidence that the inventive composition has an epigenetic effect on the consumers.

[0059] Thus, the composition provides a novel and advantageous approach for weight loss of individuals. The approach is special because of the purposeful combination of physical filling of the stomach and activation of mechanoreceptors in the mouth area through chewing, with the specifically adapted beads and composition. The composition can be varied widely in taste and appearance and thus can be pleasant for the user. The chewing of the beads can also be pleasant for the consumer, and in this regard can be similar to consumption of chewing gum. In addition, active ingredients may be included which support appetite reduction and weight loss.

EXAMPLES

Example 1: Preparation of Beads

[0060] Beads were prepared based on various dietary fibres as the main component. The dietary fibres were mostly methylcellulose and hydroxypropyl methylcellulose. Further, fibres from seaweeds such as Eucheuma, Gigartina and Chondrus were included. Such dietary fibres are known and commonly used in food technology. Stevia was included as a sweetener. Various plant extracts were included which have a pleasant taste or appearance or which have been described in the art as improving the well-being of the consumer. These comprised plant active agents such as glycyrrhizin, phytosterole, saponins, liquiritin and liquiritigenin. Wild yam contains high amounts of steroidal saponins. The Glycyrrhiza glabra (licorice) extract was enriched in active agents such as glycyrrhizin, phytosterole, saponins, liquiritin and liquiritigenin. As examples, beads were prepared with the following base formulations:

[0061] Formulation A: methylcellulose, hydroxypropyl methylcellulose, Algae mixture (Eucheuma, Gigartina, Chondrus), stevia, Glycyrrhiza glabra extract, pinapple extract (bromelain), Citrus aurantium (synephrine) extract.

[0062] Formulation B: methylcellulose, hydroxypropyl methylcellulose, Algae mixture (Eucheuma, Gigartina, Chondrus), stevia, wild yam (Dioscorea villosa) extract, Glycyrrhiza glabra extract.

[0063] Formulation C: methylcellulose, hydroxypropyl methylcellulose, Algae mixture (Eucheuma, Gigartina, Chondrus), stevia, Glycyrrhiza glabra extract, chromium polynicotinate, Mentha aquatica extract.

[0064] Formulation D: methylcellulose, hydroxypropyl methylcellulose, Algae mixture (Eucheuma, Gigartina, Chondrus), stevia, Glycyrrhiza glabra extract.

[0065] Further additives can be included into the formulation for conferring desired physical properties to the beads. Lipids, such as tartaric acid esters of fatty acid glycerides, were added as binders and to render the beads water repellant. The ingredients were mixed, kneaded and compressed into spherical beads. The beads were coated with hydromellose-phthalate (HPMC-P) by spray coating for protection and increasing water repellant properties. A formulation E with all additives is shown in table 1.

TABLE-US-00001 TABLE 1 Formulation E Ingredient mg %(w/w) Hydroxypropyl-Methylcellulose 16,800 84 Alginic acid coated with HPMC-P 1,300 6.5 Tartaric acid esters of mono-and diglycerides 950 4.8 of fatty acids Stevia 850 4.2 Glycyrrhiza glabra 100 0.5 Total 20,000 100 Spray coating: Hypromellose-Phthalat (HPMC-P) not determined

[0066] The spherical beads had a diameter of about 4 to 5 mm (FIG. 1). The food energy content of 20 g beads, which relates to a typical single dosage, was determined as 25 kJ (corresponding to 125 kJ/100 g beads; based on an energy content of non-fermentable cellulose derivatives of 0 kJ/100 g). When starting chewing the beads, the texture was slightly resilient and roughly comparable to chewing gum. It took about 30 to 60 seconds for the beads to be chewed up in the mouth.

Example 2: Preparation of Composition

[0067] Green tea containing about 20 mg5% epigallochatingelate per serving (300 ml) was used as the beverage for preparing the composition. 20 g of beads prepared according to example 1 were poured into 300 g cold green tea. The beads were water repellent and could be dispersed in the tea. The beads sank to the bottom of the cup as shown in FIG. 2. The beads did not soften or change texture and dissolve within about 40 minutes after contact with water. It took about 120 minutes for the beads to dissolve completely. Since the beads are chewed, drinking took longer than for a normal drink without beads. A typical drinking time for 300 g green tea with 20 g beads was about 5 to 20 minutes. The energy contents of inventive and some comparative compositions are summarized in table 2 below.

TABLE-US-00002 TABLE 2 Energy densities of inventive and comparative compositions Composition kJ kJ/100 g 20 g Beads (formulation E) 25 125 300 ml tea and 20 g beads (formulation B) 41.8 13.1 300 ml tea and 20 g beads (formulation D) 25.7 8.0 300 ml green tea with 10 g licorice and 1291 403.4 10 g wild yam 300 ml Citrus Green Tea (trademark Nestea, 240 80 Nestle, CH) 300 ml Green tea ice tea (trademark Lipton, 237 79 Unilever, NL)

[0068] The results demonstrate that the energy content of the beads and the composition is very low, especially when compared to commercially available green tea beverages or natural products.

Example 3: Effect of Composition

[0069] The composition was administered to individuals in order to assess the effect on weight and epigenetic factors. Trials were carried out with a composition as described in example 2 based on 300 ml green tea and 20 g beads of composition D comprising 850 mg stevia and 100 mg Glycyrrhiza glabra. The composition was administered to seven individuals once per day over time periods between 40 and 51 days. The individuals were women aged between 51 and 54 years which had previously experienced weight gain between 4 to 9 kg since menopause and were not subject to hormone therapy. The individuals had tried to reduce weight in the past by food abstinence after 4 p.m. daily, but had not been successful. Thus, they agreed to try administration of the composition once after 4 p.m. daily. The subjects were allowed to select the time of administration after 4 p.m. depending on a sensation of hunger. Further, the individuals were abstinent from food after 4 p.m. daily. The subjects were instructed to consume 500 ml green tea slowly over a period of 15 minutes. At the same time, the subjects chewed beads. The subjects were instructed to consume a number of beads appropriate for a normal chewing, to prolong chewing as long as possible and to drink the green tea simultaneously.

[0070] As a result, five of the seven subjects were able to consume the composition daily under the predetermined conditions. Two patients were only able to consume the composition under the predetermined conditions two to five times per week. An overview of the conditions and results is provided in the following table. For the five subjects who consumed the composition daily, a weekly weight loss between 500 g and 1 kg per week was observed. All women reported that consumption of the composition under the predetermined conditions reduced a feeling of hunger significantly. Thus, the women were able to continue the consumption over extended time periods, whilst food abstinence after 4 pm had failed before without the inventive composition. Side effects, such as stomach pain or digestion problems were not observed. The total weight loss observed was between 2.4 and 5.1 kg for all subjects with an average of 3.9 kg. A summary of conditions and results is provided in table 3.

[0071] In order to assess an effect on the physiological level, the concentration of proneurotensin was determined from blood of the subjects at the beginning and end of the trial. Proneurotensin is a known biomarker for weight control. Neurotensin is formed in N-cells of the small intestine and in the central nervous system. The concentration of neurotensin is greatly affected by animal fats and sugars. By daily administration of the composition, the level of proneurotensin could be lowered for all subjects at an average of 13 pm/l, which is roughly about 10%. The results are also summarized in table 3.

TABLE-US-00003 TABLE 3 Conditions and results of trials according to example 3 (diff = difference; Proneu = proneurotensin). Weight Weight Weight Proneu Proneu Proneu Subject Age start end diff start end diff Time [number] [years] [kg] [kg] [kg] [pmol/l] [pmol/l] [pmol/l] [days] 1 51 72.4 67.3 5.1 120 118 12 43 2 51 85.2 81.8 3.4 143 119 24 40 3 55 77.6 72.9 4.7 139 119 20 46 4 51 89.0 86.6 2.4 152 140 12 40 5 54 81.9 79.1 2.8 139 130 9 51 6 53 75.5 71.2 4.3 131 125 6 46 7 51 68.6 64.3 4.3 149 140 9 48 average 3.9 13

[0072] Overall, the results demonstrate a significant effect of administration of the composition on weight loss for all subjects who participated in the trial, which could not be achieved simply by food abstinence.

Example 4: Effect of Comparative Composition without Beads

[0073] In order to exclude that the positive results of example 3 are obtained because of active ingredients in the composition, a further trial was carried out. A comparable formulation F was prepared with the active ingredients of composition D of example 3. However, the composition was not provided in the form of a beverage with chewable beads. Instead, formulation F was a beverage for drinking prepared by dissolving the ingredients in the green tea.

[0074] Formulation F (32 kJ per 500 ml):

[0075] 500 ml green tea contained 100 mg Glycyrrhiza glabra, 850 mg Stevia, 35 g algea mixture (Eucheuma, Gigartina, Chondrus).

[0076] The individuals consumed formulation F once per day over time periods between 40 and 49 days. The individuals were 11 women aged between 51 and 54 years which had previously experienced weight gain between 4 to 9 kg since menopause and were not subject to hormone therapy. The individuals had tried to reduce weight in the past by food abstinence after 4 p.m. daily, but had not been successful. Thus, they agreed to drink 500 ml of formulation F once a day after 4 p.m. The subjects were allowed to select the time of administration after 4 p.m. depending on a sensation of hunger. Further, the individuals were abstinent from food after 4 p.m. daily. The subjects were instructed to consume the 500 ml formation F slowly over a period of 15 minutes.

[0077] The results are summarized in table 4 below. An average weight gain of 0.3 kg was observed for the individuals. Otherwise, no significant change of other body markers was observed. There were no significant changes in proneurotensin levels.

TABLE-US-00004 TABLE 4 Conditions and results of trials according to example 4 (diff = difference; Proneu = proneurotensin). Weight Weight Weight Proneu Proneu Proneu Time Subject Age start end diff start end diff period [number] [years] [kg] [kg] [kg] [pmol/l] [pmol/l] [pmol/l] [days] 1 51 78.6 78.1 0.5 118 117 1 41 2 53 61.8 62.3 +0.5 136 128 8 45 3 53 55.6 54.9 0.7 108 115 7 48 4 52 59.6 62.1 +1.5 118 117 1 47 5 54 73.4 73.6 +0.2 142 154 +12 49 6 52 82.3 85.8 +3.5 123 121 2 43 7 54 61.3 60.2 0.9 106 117 +11 47 8 53 64.2 63.5 0.7 134 131 3 48 9 52 84.6 84.3 0.3 147 149 +2 44 10 51 53.5 54.6 +1.1 108 114 +6 40 11 52 58.4 57.6 0.8 124 112 10 40 average +0.3 0

[0078] The results demonstrate that simply drinking green tea with dissolved dietary fibers and Glycyrrhiza glabra, stevia and algea does not stimulate weight loss and does not improve neurotensin (proneurotensin) levels. Example 3 and comparative example 4 taken together provide evidence that the effects of the inventive composition on weight loss and proneurotensin levels result from the dosage form as a beverage comprising chewable beads.