Impact of Dietary Fibre Consumption on Digestive Comfort (Fibrecomf)

University of Glasgow

Status: Enrolling

Conditions: Gastrointestinal Discomfort

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Soluble corn fibre; Dietary Supplement: Inulin; Dietary Supplement: soluble corn fibre and inulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05830032

CP/2294514

Details and patient eligibility

About

The purpose of this randomised, placebo-controlled, cross-over study is to compare the impact different fibres have on gastrointestinal symptoms when they are consumed individually or as mixtures in healthy adults. The impact of different fibres on the experience of symptoms and stool parameters will be assessed.

Full description

Global sugar consumption is higher than recommended and there are suggestions that this may be linked to the development of non-communicable diseases including dental caries, and obesity. There are many alternatives to sugars that can be used in foods including certain dietary fibres such as inulin or fructo-oligosaccharides. Most dietary fibres can be fully or partially fermented in the colon by the commensal microbiota, producing beneficial bioactive molecules. However, the rapid production of gas during the fermentation of highly soluble fermentable fibres may cause undesirable symptoms for some people. Dietary exposure to the fibres used in food reformulation, including inulin and soluble corn fibre, is increasing and the impact this may have on gastrointestinal symptoms is unclear. The impact of fibres with different physicochemical characteristics and fermentabilities may differ when consumed in mixtures compared to individually.

The aim of this study is to investigate the impact different fibres have on gastrointestinal symptoms when they are consumed individually or as mixtures and how this relates to the composition of the stool.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Self-reported healthy adults (aged 18-65y)
• Non-smokers

Exclusion criteria

• Individuals with any allergies or conditions affecting bowel health e.g. inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, coeliac disease or diverticular disease
• Individuals who are pregnant or are trying to get pregnant
• Individuals with any food allergies
• Individuals who have taken antibiotics in the past 3 months
• Individuals who regularly take medication that may modify gastrointestinal function e.g. prokinetic agents (e.g. metoclopramide), antiemetics, constipation treatments (e.g. lactulose, polyethylene glycol)
• Individuals who consume ≥25g fibre per day

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

12 participants in 4 patient groups, including a placebo group

Soluble Corn fibre

Experimental group

Description:

Soluble corn fibre (SCF) (15g fibre/day)

Treatment:

Dietary Supplement: Soluble corn fibre

Inulin

Experimental group

Description:

Inulin (In) (15g fibre/day)

Treatment:

Dietary Supplement: Inulin

Soluble corn fibre and inulin

Experimental group

Description:

SCF + In (15g/day fibre)

Treatment:

Dietary Supplement: soluble corn fibre and inulin

Control (Maltodextrin)

Placebo Comparator group

Description:

Control (Maltodextrin) (0g fibre)

Treatment:

Dietary Supplement: Maltodextrin