Metabolic Response of Intestinal Microbiota to Guar Gum Consumption

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05195255
Collaborator
(none)
12
1
1
9.9
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Prebiotic
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Prebiotic Properties of Phenolic Compounds
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Mar 31, 2022
Actual Study Completion Date :
Apr 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy subjects

Prebiotic administration

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

Outcome Measures

Primary Outcome Measures

  1. Number of daily anal gas evacuations [18 days]

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

Secondary Outcome Measures

  1. Microbiota composition by fecal analysis [18 days]

    Change from beginning of treatment to end of treatment

  2. Sensation of flatulence by scales [18 days]

    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

  3. Sensation of abdominal bloating by scales [18 days]

    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.

  4. Sensation of digestive well-being by scales [18 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Exclusion Criteria:
  • gastrointestinal symptoms

  • recent (3 months) antibiotic intake

  • change in dietary habits 4 weeks before

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT05195255
Other Study ID Numbers:
  • PR(AG)33/2021B
First Posted:
Jan 18, 2022
Last Update Posted:
Jun 9, 2022
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

Study Results

No Results Posted as of Jun 9, 2022