Metabolic Response of Intestinal Microbiota to Guar Gum Consumption

NCT05195255 | Completed

• 1 other identifier: PR(AG)33/2021B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Some components of the diet are not absorbed in the small intestine and pass into the colon, where they may be fermented by the microbiota, releasing gas. A series of recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate to colonic bacteria and change their composition, thereby producing beneficial effects to the host. These products are fermented by bacteria and at initial intake increase gas production; however, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production. Hence, intestinal gas production may serve as an index of microbiota metabolic activity. Gas production may induce gas-related symptoms, such as flatulence, abdominal bloating and distention, and the symptoms improve when the microbiota adapts to the prebiotic and gas production declines. Guar gum is classified as a fiber, but it remains uncertain whether and to what extent it is fermented by colonic microbiota and whether it has prebiotic properties. Aim: to determine the metabolic reaction of intestinal microbiota in response to guar gum consumption, specifically, the extent of initial fermentation and subsequent adaptation.Design: Single-centre, single arm, open label, proof-of-concept study testing the effect of guar gum on microbiota metabolism and adaptation in healthy subjects Intervention: guar gum (8 g/d) will be administered for 18 days. Outcomes: during 4 days immediately before, at the beginning and at the end of the administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) perception of digestive sensations by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.

Conditions

Healthy

Keywords

intestinal gas; healthy subjects; microbiota; prebiotic

Outcome Measures

Primary Outcomes (1)

• Number of daily anal gas evacuations

  Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

  18 days

Secondary Outcomes (4)

• Microbiota composition by fecal analysis

  18 days

• Sensation of flatulence by scales

  18 days

• Sensation of abdominal bloating by scales

  18 days

• Sensation of digestive well-being by scales

  18 days

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Prebiotic administration

Dietary Supplement: Prebiotic

Interventions

Prebiotic DIETARY_SUPPLEMENT

Guar gum (8 g/d) will be administered for 18 days

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• gastrointestinal symptoms
• recent (3 months) antibiotic intake
• change in dietary habits 4 weeks before

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: January 18, 2022
• Study Start: July 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 29, 2022
• Last Updated: June 9, 2022

Record last verified: 2021-11

Locations

ES (1)