Thickener composition, thickened nutritive products, methods for preparing thickened nutritive products, and methods for providing nutrition

Abstract

Disclosed are thickener compositions composed of xanthan gum and a chelating agent, such as ascorbic acid. The chelating agent is present in an amount with respect to said xanthan such that, when said thickener composition is used to thicken a food product, at least one mineral selected from the group consisting of iron, zinc, and calcium present in said food product is relatively more bioavailable than the mineral would be in the absence of said chelating agent. The thickener composition finds particular applicability for use with baby formulas and breast milk intended for dysphagic infants. Also disclosed are baby formulas and thickened breast milk formulations, methods for preparing same, and methods for providing nutrition.

Claims

.[.1. A thickened breast milk product comprising: breast milk; xanthan gum, said xanthan gum being present in an amount from 1 to 2% by weight and a chelating agent comprising ascorbic acid from 0.001% to 0.005% by weight, to increase the bioavailability of at least one mineral selected from the group consisting of iron, zinc, and calcium relative to the absence of the chelating agent; wherein the ratio by dry weight of xanthan gum to ascorbic acid is between about 2000:1.5 to about 1000:2.5..].

.[.2. The thickened breast milk product of claim 1, wherein the xanthan is present in an amount sufficient to thicken the breast milk to a viscosity of between about 100-1000 centipoise..].

.[.3. The thickened breast milk product of claim 1, wherein the bioavailability of calcium in said thickened breast milk product is at least about 80 percent of the bioavailability of calcium of unthickened breast milk..].

.[.4. The thickened breast milk product of claim 1, wherein the bioavailability of iron in said thickened breast milk product is at least about 80 percent of the bioavailability of iron of unthickened breast milk..].

.[.5. The thickened breast milk product of claim 1, wherein the bioavailability of zinc in said thickened breast milk product is at least about 80 percent of the bioavailability of the zinc of unthickened breast milk..].

.[.6. The thickened breast milk product of claim 1, wherein the chelating agent is ascorbic acid; wherein the xanthan is present in an amount sufficient to thicken the breast milk to a viscosity of between about 100-1000 centipoise; wherein the bioavailability of calcium in said thickened breast milk product is at least about 80 percent of the bioavailability of calcium of unthickened breast milk; wherein the bioavailability of iron in said thickened breast milk product is at least about 80 percent of the bioavailability of iron of unthickened breast milk; and wherein the bioavailability of zinc in said thickened breast milk product is at least about 80 percent of the bioavailability of the zinc of unthickened breast milk..].

.Iadd.7. A thickened food product made by a method comprising: mixing a food product and a thickener composition in a ratio effective to thicken said food product; said food product comprising at least one of calcium, zinc, or iron; said thickener composition comprising xanthan gum, said xanthan gum being present in an amount from 1 to 2% by weight, blended with a chelating agent, said chelating agent comprising ascorbic acid from 0.001% to 0.005% by weight; wherein the ratio by dry weight of xanthan gum to ascorbic acid is between about 2000:1.5 to about 1000:2.5; said thickener added in an amount to provide an amount of chelating agent effective to increase the bioavailability to a dysphagic consumer of at least one of calcium, zinc, or iron relative to the absence of the chelating agent, wherein the amount of thickener added thickens the food product to a viscosity of about 150 centipoise to about 2000 centipoise, wherein the thickening composition comprises 40-60 wt. % xanthan gum and 40-60% dissolution agent. .Iaddend.

.Iadd.8. The thickened food product of claim 7, wherein the bioavailability of calcium in said thickened food product is at least about 80 percent of the bioavailability of calcium in the food product without the xanthan gum and the chelating agent. .Iaddend.

.Iadd.9. The thickened food product of claim 7, wherein the bioavailability of iron in said thickened food product is at least about 80 percent of the bioavailability of iron in the food product without the xanthan gum and the chelating agent. .Iaddend.

.Iadd.10. The thickened food product of claim 7, wherein the bioavailability of zinc in said thickened food product is at least about 80 percent of the bioavailability of zinc in the food product without the xanthan gum and the chelating agent. .Iaddend.

.Iadd.11. The thickened food product of claim 7, wherein the food product comprises water. .Iaddend.

.Iadd.12. The thickened food product of claim 7, wherein the food product comprises vegetable oil. .Iaddend.

.Iadd.13. The thickened food product of claim 7, wherein the food product comprises milk. .Iaddend.

.Iadd.14. The thickened food product of claim 7, wherein the thickener composition further includes a dissolution agent. .Iaddend.

.Iadd.15. The thickened food product of claim 7, wherein the thickening composition comprises 40-60 wt. % xanthan gum and 40-60% dissolution agent. .Iaddend.

.Iadd.16. The thickened food product of claim 15, wherein the dissolution agent is maltodextrin. .Iaddend.

Description

EXAMPLES

(1) The following examples and comparative examples are provided to illustrate certain embodiments of the invention, but should not be construed as limiting the invention in scope.

Baseline Determination of Calcium, Zinc, and Iron

(2) Milk samples from infant formula (SIMILAC NEOSURE, Abbott Laboratories, Abbott Park, Ill.) and human breast milk were prepared. Six piglets were fed with a 5% glucose solution in deionized water ad libitum for 36 hours prior to the administration of the milk samples to the test subjects to flush minerals from the blood stream and achieve homeostasis. At the end of the 36 hours of glucose feeding, three of the six piglets were provided with non-thickened infant formula, and the remaining three were provided with non-thickened human breast milk. The samples were provided to each test subject ad libitum for about 48 hours. At the end of 48 hours, approximately 2 ml of blood was drawn from the test subjects and analyzed for calcium, iron, and zinc levels in accordance with the methods described in Miller-Ihli, Trace element determinations in foods and biological samples using inductively coupled plasma atomic emission spectrometry and flame atomic absorption spectrometry, J. Agr & Food Chem. 44:9 (1996). The average values were calculated and are shown in the table below.

(3) TABLE-US-00003 Milk Type Iron (mg/L) Calcium (mg/L) Zn (mg/L) Formula 0.071 30.50 1.05 Breast Milk 0.065 28.45 1.14

(4) The above results in were obtained from calculations based on test subject data show in the table below.

(5) TABLE-US-00004 Piglet I.D Fe (mg/L) Ca (mg/L) Zn (mg/L) Baseline Group B-007 0.075 30.21 1.02 Formula B-010 0.071 31.02 1.05 B-011 0.068 30.27 1.07 Average 0.071 30.50 1.05 Baseline Group B-014 0.068 28.1 1.12 Breast Milk B-028 0.063 29.07 1.09 B-032 0.064 28.19 1.21 Average 0.065 28.45 1.14

Example 1 and Comparative Example 1

(6) Test subjects provided with xanthan only thickened formula or breast milk, and test subject provided with xanthan and ascorbic acid thickened formula or breast milk. Prior to providing test subject with xanthan only thickened formula or breast milk, and with xanthan and ascorbic acid thickened formula or breast milk, test subjects were fed with a 5% glucose solution as described in Comparative Example 1, and provided with the milk samples ad libitum for about 48 hours.

(7) Samples of xanthan only thickened formula or breast milk, and xanthan and ascorbic acid thickened formula or breast milk were prepared in amounts as shown in the table below:

(8) TABLE-US-00005 Example 1 Comparative Example 1 Xanthan and Ascorbic Xanthan Thickened Milk Acid Thickened Milk Xanthan 1.5% Xanthan 1.5% Ascorbic Acid Ascorbic Acid 0.002% Milk 98.5% Milk ~98.5% (Formula or Breast Milk) (Formula or Breast Milk)

(9) Of twelve test subjects, six test subjects were provided with xanthan thickened formula, and the remaining six were provided with xanthan thickened breast milk. Blood levels of iron, calcium, and zinc for tests subjects provided with xanthan thickened milk were obtained as described above.

(10) The same tests subjects administered xanthan thickened formulas were administered xanthan and ascorbic acid thickened formula on a separate occasion. The same tests subjects given xanthan thickened breast milk were administered xanthan and ascorbic acid thickened breast milk on a separate occasion. Blood levels of iron, calcium, and zinc for tests subjects provided with xanthan and ascorbic acid thickened milk were obtained as described in Comparative Example 1 above.

(11) Average blood levels of iron, calcium, and zinc were calculated for the thickened formula with results as shown in the table below:

(12) Thickened Formula

(13) TABLE-US-00006 Comparison of Blood Mineral Levels (mg/L) Between Xanthan Thickened Formula and Xanthan and Ascorbic Acid Thickened Formula Xanthan and Xanthan Ascorbic Acid Mineral Thickened Formula Thickened Formula Percent Type (Comparative Example 1) (Example 1) Increase Iron 0.043 0.066 53.5 Calcium 27.53 30 9.0 Zinc 0.95 1.04 9.5

(14) The above results were obtained from calculations based on test subject data show in the table below:

(15) TABLE-US-00007 Piglet I.D Fe (mg/L) Ca (mg/L) Zn (mg/L) Test Subjects B-072 0.046 28.28 0.96 Fed Xanthan B-021 0.051 27.89 0.96 Thickened B-061 0.039 27.27 0.93 Formula B-111 0.041 27.32 0.89 B-098 0.038 28.09 1.01 B-025 0.042 26.32 0.93 Average 0.043 27.53 0.95 Test Subjects B-072 0.071 29.07 0.98 Fed Xanthan and B-021 0.068 30.08 1 Ascorbic Acid B-061 0.065 29.45 0.99 Thickened B-111 0.062 29.9 1.01 Formula B-098 0.07 30.8 1.1 B-025 0.059 30.71 1.14 Average 0.066 30.00 1.04

(16) Similar results were obtained for the thickened breast milk as shown in the table below:

(17) TABLE-US-00008 Comparison of Blood Mineral Levels (mg/L) Between Xanthan Thickened Breast Milk and Xanthan and Ascorbic Acid Thickened Breast Milk Xanthan and Xanthan Ascorbic Acid Mineral Thickened Breast Milk Thickened Breast Milk Percent Type (Example 1) (Example 1) Increase Iron 0.049 0.071 44.9 Calcium 25.63 28.37 10.7 Zinc 0.85 0.96 12.9

(18) The above results were obtained from calculations based on test subject data show in the table below.

(19) TABLE-US-00009 Piglet I.D Fe (mg/L) Ca (mg/L) Zn (mg/L) Test Subjects B-017 0.049 22.8 0.92 Fed Xanthan B-029 0.045 25.34 0.95 Thickened B-053 0.051 26.79 0.82 Formula B-042 0.053 25.67 0.85 B-050 0.048 26.05 0.83 B-038 0.048 27.14 0.75 Average 0.049 25.63 0.85 Test Subjects B-017 0.066 28.22 0.98 Fed Xanthan and B-029 0.069 28.95 0.94 Ascorbic Acid B-053 0.076 29.82 0.96 Thickened B-042 0.073 28.09 1.04 Formula B-050 0.062 27.22 0.92 B-038 0.078 27.89 0.89 Average 0.071 28.37 0.96

(20) The above results demonstrate that, in comparison to baseline levels of minerals in the bloodstream from administering un-thickened infant formula and un-thickened breast milk in Comparative Example 1, bloodstream mineral levels of infant formula and breast milk thickened with xanthan are less than baseline levels, indicating that the minerals and likely binding to xanthan, resulting in decreased levels in the bloodstream. The use of ascorbic acid results in improved bioavailability of calcium, iron, and zinc over infant formula and breast milk thickened only with xanthan.

(21) A comparison between average baseline mineral levels from Comparative Example 1 and average mineral levels resulting from milk thickened with xanthan only is presented in the table below.

(22) TABLE-US-00010 Comparison of Baseline Blood Mineral Levels and Xanthan Thickened Milk Xanthan Thickened Formula Xanthan Thickened Breast Milk Fe Ca Zn Fe Ca Zn Baseline 0.071 30.50 1.05 Baseline 0.065 28.45 1.14 Level Level (mg/L) (mg/L) Xanthan 0.043 27.53 0.95 Xanthan 0.049 25.63 0.85 Thickened Thickened Formula Breast Milk Level Level (mg/L) (mg/L) Difference 0.028 2.97 0.1 Difference 0.016 2.82 0.29 (mg/L) (mg/L) Percent 39.4 9.7 9.5 Percent 24.6 9.9 25.1 Difference Difference

(23) In comparison to baseline levels of minerals in the bloodstream from administering un-thickened infant formula and un-thickened breast milk in Comparative Example 1, bloodstream mineral levels of infant formula and breast milk thickened with xanthan and ascorbic acid are closer to baseline levels.

(24) A comparison between average baseline mineral levels from Comparative Example 1 and average mineral levels resulting from milk thickened with xanthan and ascorbic acid is presented in the table below.

(25) TABLE-US-00011 Comparison of Baseline Blood Mineral Levels and Xanthan and Ascorbic Acid Thickened Milk Xanthan and Ascorbic Acid Xanthan and Ascorbic Acid Thickened Formula Thickened Breast Milk Fe Ca Zn Fe Ca Zn Baseline 0.071 30.5 1.05 Baseline 0.065 28.45 1.14 Level Level (mg/L) (mg/L) Xanthan + 0.066 30.0 1.04 Xanthan + 0.071 28.37 0.96 Ascorbic Ascorbic Acid Acid Thickened Thickened Formula Breast Milk Level Level (mg/L) (mg/L) Difference 0.005 0.5 0.01 Difference 0.006 0.09 0.19 (mg/L) (mg/L) Percent 7.71 1.63 0.96 Percent 8.7 0.31 16.23 Difference Difference

(26) Compared to baseline levels, xanthan-only thickened milk resulted in a decreased availability of Fe, Ca, and Zn, which is believed to be indicative of binding of Fe, Ca, and Zn to xanthan. Xanthan- and ascorbic-acid-thickened milk resulted in availability levels much closer to baseline levels, which is believed to be indicative of ascorbic acid intervening with binding of Fe, Ca, and Zn to xanthan. The 8.7 value for iron indicates that more iron was bioavailable in the thickened milk than in the unthickened milk, and this is believed to be due to a reduction of Fe.sup.3+ or other iron in the milk.

Example 2

(27) A powdered thickener composition is prepared by combining xanthan gum, ascorbic acid, and maltodextrin in the amounts listed in the table below:

(28) TABLE-US-00012 Thickener Composition Ingredient Wt % Xanthan Gum 55% Ascorbic Acid 0.07%.sup. Maltodextrin 45%

(29) These ingredients are combined in a mixer and mixed until the components are evenly distributed.

Example 3

(30) A thickened breast milk product is prepared by combining 5.5 g of the thickener composition of Example 2 with 200 mL of breast milk. The thickened breast milk product has a composition as shown in the table below.

(31) TABLE-US-00013 Thickened Breast Milk Product Component Wt % Xanthan Gum 1.5% Ascorbic Acid 0.002% Maltodextrin 1.2% Breast Milk 97.3%

(32) The thickener composition is added to a feeding bottle containing 200 mL of breast milk. The contents of the feeding bottle are then agitated by shaking for about 10 seconds until the thickener composition has dispersed and the contents are thickened.

Example 4

(33) A baby formula product is prepared by combining 35.2 grams of ENFAMIL PREMIUM Infant (Mead Johnson & Company, LLC) and 250 mL of water according to label instructions, and 8 g of the thickener composition of Example 2. The thickened baby formula product has a composition as shown in the table below.

(34) TABLE-US-00014 Thickened Baby Formula Product Component Wt % Xanthan Gum 1.5% Ascorbic Acid 0.002% Maltodextrin 1.2% ENFAMIL PREMIUM Infant 12.0% Water 85.3%

(35) Baby formula and the thickener composition are combined into an empty feeding bottle. Water is added to the feeding bottle. The contents of the feeding bottle are then agitated by stirring with a spoon for about 20 seconds until the powdered components are evenly dispersed and the baby formula is thickened.

Example 5

(36) To provide breast milk or baby formula to an infant with dysphagia, the thickened breast milk product of Example 3 or baby formula of Example 4 is administered to an infant with dysphagia. The thickened breast milk is thickened to have a viscosity of between 100 to 1000 centipoise.

(37) Except as otherwise clearly indicated by context, all weight percentages expressed herein are on a dry solids basis.

(38) All references cited herein are hereby incorporated by reference in their entireties.

(39) Uses of singular terms such as a, an, are intended to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms comprising, having, including, and containing are to be construed as open-ended terms. Any description of certain embodiments as preferred embodiments, and other recitation of embodiments, features, or ranges as being preferred, or suggestion that such are preferred, is not deemed to be limiting. The invention is deemed to encompass embodiments that are presently deemed to be less preferred and that may be described herein as such. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., such as) provided herein, is intended to illuminate the invention and does not pose a limitation on the scope of the invention. Any statement herein as to the nature or benefits of the invention or of the preferred embodiments is not intended to be limiting. This invention includes all modifications and equivalents of the subject matter recited herein as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. The description herein of any reference or patent, even if identified as prior, is not intended to constitute a concession that such reference or patent is available as prior art against the present invention. No unclaimed language should be deemed to limit the invention in scope. Any statements or suggestions herein that certain features constitute a component of the claimed invention are not intended to be limiting unless reflected in the appended claims. Neither the marking of the patent number on any product nor the identification of the patent number in connection with any service should be deemed a representation that all embodiments described herein are incorporated into such product or service.