Metabolic Response of Intestinal Microbiota to Guar Gum Consumption

Healthy Clinical Trial

Official title:

Prebiotic Properties of Phenolic Compounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195255
• Other study ID #: PR(AG)33/2021B
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: November 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 29, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Prebiotic
Guar gum (8 g/d) will be administered for 18 days

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microbiota composition by fecal analysis	Change from beginning of treatment to end of treatment	18 days
Secondary	Sensation of flatulence by scales	Sensation of flatulence measured on a 0-10 scale graded from 0 (no flatulence) to 10 (very intense sensation). Change from beginning of treatment to end of treatment	18 days
Secondary	Sensation of abdominal bloating by scales	Sensation of abdominal bloating measured on a 0-10 scale graded from 0 (no bloating) to 10 (very intense sensation). Change from beginning of treatment to end of treatment.	18 days
Secondary	Sensation of digestive well-being by scales	Sensation of digestive well-being measured on a -5 to +5 scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation). Change from beginning of treatment to end of treatment.	18 days