US-12616661-B2 - Composition for type II diabetics and for use in providing sustained energy release over time

Abstract

A composition for use in a method of providing sustained energy release over time in a subject is described. The composition comprises or consists of microparticles comprising high glycaemic index (GI) carbohydrate contained within a gastric-resistant, ileal-sensitive, GLP-1 stimulative, non-porous carrier configured for release of the high GI carbohydrate in the ileum, wherein the composition is administered orally to the subject.

Inventors

• Sinead Bleiel
• Robert Kent
• Neil Gerard Docherty
• Carel Wynand Le Roux

Assignees

• ANABIO TECHNOLOGIES LTD.

Dates

Publication Date

20260505

Application Date

20190307

Priority Date

20180307

Claims (20)

1. 1 . A method of regulating post-prandial blood sugar levels in a diabetic or pre-diabetic subject, the method comprising orally administering to the subject a composition comprising or consisting of microparticles comprising a high glycaemic index (GI) carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carrier configured for release of the high GI carbohydrate in the distal ileum, in which the non-porous carrier comprises polymerised protein in an amount sufficient to inhibit degradation of the microparticles in the duodenum at least 48 minutes after oral administration, and in which the microparticles release the high GI carbohydrate in the distal ileum wherein the microparticles have two coats of polymerised denatured protein.
2. 2 . A method of normalising blood glucose homeostasis in a diabetic or pre-diabetic subject, the method comprising orally administering to the subject a composition comprising or consisting of microparticles comprising a high glycaemic index (GI) carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carrier configured for release of the high GI carbohydrate in the distal ileum, in which the non-porous carrier comprises polymerised protein in an amount sufficient to inhibit degradation of the microparticles in the duodenum at least 48 minutes after oral administration, and in which the microparticles release the high GI carbohydrate in the distal ileum wherein the microparticles have two coats of polymerised denatured protein.
3. 3 . A method of increasing or stimulating a GLP-1 response in a subject having a metabolic disorder characterised by dysregulated insulin production, the method comprising orally administering to the subject a composition comprising or consisting of microparticles comprising high glycaemic index (GI) carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carrier configured for release of the high GI carbohydrate in the distal ileum, in which the non-porous carrier comprises polymerised protein in an amount sufficient to inhibit degradation of the microparticles in the duodenum at least 48 minutes after oral administration, and in which the microparticles release the high GI carbohydrate in the distal ileum wherein the microparticles have two coats of polymerised denatured protein.
4. 4 . A method according to claim 2 , in which the subject has Type II diabetes.
5. 5 . A method according to claim 1 , in which the polymerised protein is denatured or hydrolysed protein.
6. 6 . A method according to claim 1 , in which the polymerised protein is dairy or plant protein.
7. 7 . A method according to claim 1 , in which the composition is administered 1 to 3 hours before a meal.
8. 8 . A method according to claim 1 , in which the microparticle has a core-shell morphology with a high GI carbohydrate core in which the carrier comprises a membrane surrounding the core.
9. 9 . A method according to claim 1 , in which the core consists essentially of high GI carbohydrate.
10. 10 . A method according claim 1 , in which the non-porous carrier comprises a matrix and in which the high GI carbohydrate is dispersed throughout the matrix.
11. 11 . A method according to claim 1 , in which the high GI carbohydrate is in solid or liquid form.
12. 12 . A method according to claim 1 , in which the composition is in a unit dose form, in which the unit dose composition comprises 100 to 1000 Kcal of high GI carbohydrate contained within the microparticles.
13. 13 . A method according to claim 1 , in which the high GI carbohydrate is a disaccharide.
14. 14 . A method of providing sustained energy release over time in a healthy subject, the method comprising orally administering the composition to the subject, the composition comprising or consisting of microparticles comprising a high glycaemic index (GI) carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carrier configured for release of the high GI carbohydrate in the distal ileum, in which the non-porous carrier comprises polymerised protein in an amount sufficient to inhibit degradation of the microparticles in the duodenum at least 48 minutes after oral administration, and in which the microparticles release the high GI carbohydrate in the distal ileum wherein the microparticles have two coats of polymerised denatured protein.
15. 15 . A method according to claim 14 , in which the non-porous carrier comprises polymerised hydrolysed denatured protein.
16. 16 . A method according to claim 14 , in which the non-porous carrier comprises polymerised plant protein.
17. 17 . A method according to claim 14 , in which the composition is administered 1 to 3 hours before a meal.
18. 18 . A method according to claim 14 , in which the composition is provided in a unit dose form, and in which the composition comprises 100 to 1000 Kcal of the high GI carbohydrate that is contained within the microparticles.
19. 19 . The method of claim 1 , wherein the regulating of the post-prandial blood sugar levels in the subject comprises attenuating or inhibiting spikes in the post-prandial blood sugar levels in the subject compared to spikes in post-prandial blood sugar levels of a subject orally administered a composition containing the same type and amount of carbohydrate in which the carbohydrate is not protected from gastric release.
20. 20 . A method of regulating post-prandial blood sugar levels in a diabetic or pre-diabetic subject, the method comprising orally administering to the subject a composition comprising or consisting of microparticles comprising a high glycaemic index (GI) carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carrier configured for release of the high GI carbohydrate in the distal ileum, in which the non-porous carrier comprises polymerised protein in an amount sufficient to inhibit degradation of the microparticles in the duodenum at least 48 minutes after oral administration, and in which the microparticles release the high GI carbohydrate in the distal ileum wherein the microparticles have two coats of polymerised denatured protein and wherein the microparticles are formed by a method comprising the steps of: providing solid carbohydrate microparticles on a fluidised bed; spraying a denatured protein solution onto the bed to coat the carbohydrate particles and form microparticles; and drying the microparticles, wherein a second denatured protein solution is sprayed on to the dried microparticles.

Description

This application is the U.S. National Stage of International Application No. PCT/EP2019/055792, filed on Mar. 7, 2019, which designates the U.S., published in English, and claims priority under 35 U.S.C. § 119 or 365 (c) to European Application No. 18160601.3, filed on Mar. 7, 2018. The entire teachings of the above applications are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to a composition for use in providing sustained energy release over time and regulation of post-prandial blood sugar levels. Also contemplated are methods of delivering a high glycaemic index (GI) carbohydrate to the bloodstream of a mammal. BACKGROUND TO THE INVENTION The absorption profile of carbohydrates in the human gut depends on the type of carbohydrate involved, and in particular the glycaemic index (GI) value of the carbohydrate. Complex carbohydrates, such as are found in peas, beans, vegetables and whole grains have a low GI value (Index less than 55), as they have to be broken down in the human gut and therefore are absorbed in the bloodstream slowly providing sustained energy release without post-prandial peaks in blood sugar levels. In contrast, simple carbohydrates (i.e. monosaccharides and disaccharides) are absorbed into the blood stream quickly, resulting in spikes in blood sugar levels within 60-90 minutes of consumption. The body has to work hard to absorb and metabolise simple sugars so quickly, which leads to a feeling of tiredness in the subject. In subjects with certain metabolic disorders, especially those with dysregulated insulin production such a Type II diabetes, the spikes in blood sugar levels that are characteristic of consumption of high GI sugars can be extremely dangerous, as insufficient insulin is available to adequately metabolise the high blood sugar levels. Subjects with Type II diabetes therefore have to avoid high energy sugar products, and satisfy their energy needs using lower energy products, which can result in insufficient calorific intake. It is an object of the invention to overcome at least one of the above-referenced problems. SUMMARY OF THE INVENTION The present invention addresses the need for a food product that contains high GI carbohydrate that is absorbed into the bloodstream in a sustained manner with attenuated post-prandial spikes in blood sugar levels. The sugar is contained within a gastric-resistant carrier configured for transit through the stomach of a mammal and ileal release. Data obtained by the applicant (FIGS. 3A-3B) shows that when sugars are protected during gastric transit and released in the ileum/distal bowel, the energy is released over time in a sustained manner and the spikes in blood sugar levels that occur with conventional sugar delivery are avoided, making the composition of the invention suitable for use by patients with metabolic disorders such as Type II diabetes or metabolic syndrome. In addition, the composition provides the energy content of a high GI sugar, with a release profile of low GI sugar, which allows for use by diabetic subjects who would otherwise have to avoid products containing high GI sugars. The composition may be taken as a meal replacement (and may include other nutritional components such as protein and fat), or it may be taken between meals to help regulate glucose levels between meals, or it may be taken with a meal including non-coated carbohydrates, where it helps attenuate spikes in blood sugar levels attributable to the non-coated carbohydrates. The coated high GI sugar is typically provided in the form of a microparticulate, and the microparticulate may have a core-shell morphology with a carbohydrate core contained within a gastric resistant, ileal-sensitive, shell, or may have a multinuclear morphology with pockets of carbohydrate dispersed throughout a continuous matrix. The composition may be a microparticulate powder, or a nutritional composition containing the microparticulate, for example a food or beverage. The composition may also be administered to an at-risk population (diabetics, pre-diabetics, obese subjects) to regulate post-prandial blood glucose levels in these subjects, or to increase sensitivity to insulin. Surprisingly, the Applicant has discovered that the microparticulate powder has a sweet taste, despite the sucrose being contained within a protective shell (FIG. 2). According to a first aspect of the present invention, there is provided a composition for use in a method of regulating post-prandial blood sugar levels, the composition comprising carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carrier configured for release of the carbohydrate in the distal ileum. According to another aspect of the present invention, there is provided a composition for use in a method of inhibiting post-prandial spikes blood sugar levels, the composition comprising carbohydrate contained within a gastric-resistant, ileal-sensitive, non-porous carri