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EP-4739329-A1 - DIETARY FIBRE FORMULATIONS

EP4739329A1EP 4739329 A1EP4739329 A1EP 4739329A1EP-4739329-A1

Abstract

A method of treating a person suffering from Irritable Bowel Syndrome (IBS) and other gut-related conditions which involves providing a source of fibre while not aggravating the IBS symptoms in the person, where the method comprises: administering to the person a dietary fibre formulation comprising a ratio of approximately 3 parts high amylose maize starch (HAMS) to 1 part psyllium; wherein the person is administered increasing volumes of the formulation for at least two weeks in an initial ramp-up period; wherein the psyllium protects against fermentation of the HAMS as the formulation passes through the proximal colon, and wherein the HAMS can be fermented in the distal colon of the person to produce butyrate and faeces; and wherein the symptoms of IBS in the person are not substantially aggravated by administration of the formulation.

Inventors

  • DEVINE, Amanda
  • CHRISTOPHERSEN, CLAUS

Assignees

  • Edith Cowan University

Dates

Publication Date
20260513
Application Date
20240702

Claims (16)

  1. 1. A method of treating a person suffering from Irritable Bowel Syndrome (IBS), the method comprising: administering to the person a dietary fibre formulation comprising a ratio of approximately 3 parts high amylose maize starch (HAMS) to 1 part psyllium; wherein the person is administered increasing volumes of the formulation for at least two weeks in an initial ramp-up period; wherein the psyllium protects against fermentation of the HAMS as the formulation passes through the proximal colon, and wherein the HAMS can be fermented in the distal colon of the person to produce butyrate and faeces; and wherein the symptoms of IBS in the person are not substantially aggravated by administration of the formulation.
  2. 2. A method according to claim 1 , wherein the initial ramp up period comprises approximately three weeks.
  3. 3. A method according to claim 1 or claim 2, wherein the initial ramp up period comprises two days of 5 g dose of dietary fibre formulation.
  4. 4. A method according to any one of the preceding claims, wherein the initial ramp up period comprises two days of 5 g/day dose of dietary fibre formulation followed by two days of 10 g/day dose of dietary fibre formulation.
  5. 5. A method according to any one of the preceding claims, wherein the initial ramp up period comprises two days of 5 g/day dose of dietary fibre formulation followed by two days of 10 g/day dose of dietary fibre formulation, followed by three days of 20 g/day dose of dietary fibre formulation.
  6. 6. A method according to any one of the preceding claims, wherein the initial ramp up period comprises two days of 5 g/day dose of dietary fibre formulation followed by two days of 10 g/day dose of dietary fibre formulation, followed by three days of 20 g/day dose of dietary fibre formulation, followed by 11 days of 40 g/day dose of dietary fibre formulation.
  7. 7. A method according to any one of the preceding claims, wherein the ramp up period of increasing amounts of dietary fibre formulation enables the gut biome of the person to adjust to the increase in total dietary fibre and fermentable fibres.
  8. 8. A method according to any one of the preceding claims, wherein following the initial ramp up period is a period of maintenance comprising a dose of between approximately 20 g/day to 30 g/day dose of dietary fibre formulation.
  9. 9. A method according to any one of claims 3 to 8, wherein the dose is divided into more than one administration per day.
  10. 10. A method according to claim 9, wherein half of the dose is administered twice a day, or a third of the dose is administered three times a day.
  11. 11. A method according to any one of the preceding claims, wherein the formulation can be administered as a dietary supplement.
  12. 12. A method according to any one of claims 1 to 10, wherein the formulation can be administered in combination with one or more food products.
  13. 13. A method according to any one of the preceding claims, wherein the persons comprise athletes or sportspeople.
  14. 14. A method according to any one of claims 1 to 12, wherein the persons comprise those taking the formulation for weight loss.
  15. 15. A method according to any one of claims 1 to 12, wherein the persons comprise those taking the formulation as a preventative for colorectal cancer due to increasing production of butyrate in the colon of the person.
  16. 16. A method according to any one of claims 1 to 12, wherein the persons comprise those taking the formulation for gut repair and where medication use negatively effects the persons microbiome in their gut.

Description

Dietary Fibre Formulations Field of the Invention [0001 ] The invention relates to dietary fibre formulations and dosage regimen for persons that suffer from Irritable Bowel Syndrome (IBS) and other gut-related conditions that provides a source of fibre while not aggravating the IBS symptoms in the persons. Background [0002] The following discussion of the background art is intended to facilitate an understanding of the present invention only. It should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was part of the common general knowledge as at the priority date of the application. [0003] With their relatively safe and inexpensive characteristics, dietary fibres can be widely applied to improve symptoms for people with IBS. However, it is typically difficult for individuals with IBS to find fibre-rich foods that are potentially low in FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols), or those they can tolerate well in order to avoid worsening symptoms. [0004] Therefore, it would be favourable and cost-effective for individuals with IBS if they could manage the disorder by supplementing their usual diet with a combination of certain isolated fibres that optimise their gut microenvironment and gut function rather than introducing foods which exacerbate their symptoms. This could also ensure they maintain overall diet quality whilst overcoming potential challenges and minimising the possible detrimental effects of following a low FODMAP diet. [0005] There is evidence in the literature that a combination of isolated fibres as a dietary supplement, may be an option for IBS patients to improve their gut health (So et al., 2022) and a number have been trialed. However, in IBS patients, short-chain carbohydrates resist digestion in the small intestine and are rapidly fermentable in the proximal colon, where they typically result in aggravated gastrointestinal symptoms. [0006] Thus, there is still a need for sufferers of IBS and other similar conditions that aggravate gastrointestinal systems to obtain alternative sources of fibre. Summary of Invention [0007] In a first aspect, the invention provides a dietary fibre formulation for use, or when used, in the treatment of IBS, the formulation comprising: one soluble highly fermentable dietary fibre; and one soluble gel-forming partly fermentable dietary fibre also containing insoluble fibre. [0008] In a preferred embodiment, the one soluble dietary fibre is High Amylose Maize Starch (HAMS). The HAMS preferably comprises approximately 40% resistant starch (RS). [0009] In a preferred embodiment, the other soluble gel-forming partly fermentable fibre (psyllium). The psyllium preferably comprises powdered psyllium. The psyllium preferably comprises approximately 70% fibre w/w. [0010] In a preferred embodiment, the formulation comprises an approximately 3:1 ratio of approximately 3 parts one soluble highly fermentable dietary fibre, to approximately 1 part of- soluble gel-forming partly fermentable dietary fibre. [001 1 ] In a preferred embodiment, the formulation comprises an approximately 3:1 ratio of approximately 3 parts HAMS, to approximately 1 part psyllium. [0012] In an embodiment, the formulation comprises additional components. The additional components may comprise additives. In an embodiment, the additives comprise flavours, for example, from freeze-dried fruits and vegetables. Such naturally sourced flavours from freeze-dried fruits and vegetables can provide additional beneficial phytochemicals and phenolic compounds to the person consuming the formulation. [0013] In a second aspect, the invention provides a method of treating a person suffering from IBS or another condition comprising aggravated gastrointestinal symptoms, the method comprising: administering to the person a dietary fibre formulation as described herein. [0014] In a third aspect, the invention provides a method of treating a person suffering from Irritable Bowel Syndrome (IBS), the method comprising: administering to the person a dietary fibre formulation comprising a ratio of approximately 3 parts high amylose maize starch (HAMS) to 1 part psyllium; wherein the person is administered increasing volumes of the formulation for at least two weeks in an initial ramp-up period; wherein the psyllium protects against fermentation of the HAMS as the formulation passes through the proximal colon, and wherein the HAMS can be fermented in the distal colon of the person to produce butyrate to promote gut health; and wherein the symptoms of IBS in the person are not substantially aggravated by administration of the formulation. [0015] In a fourth aspect, the invention provides a use of a dietary fibre formulation as described herein for not exacerbating, or alleviating the symptoms of a person suffering from IBS or another condition comprising aggravated gastrointestinal symptoms. [0016] In an embodimen