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Clinical Trials/NCT05197218
NCT05197218CompletedNot Applicable

Prebiotic Properties of Phenolic Compounds

Hospital Universitari Vall d'Hebron Research Institute2 sites in 1 country24 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Number of daily anal gas evacuations

Study Overview

Brief Summary

Gas evacuated per anus originates by-and-large in the colon, where unabsorbed meal residues are fermented by colonic bacteria. Within subjects, gas output varies in relation to the diet. However, there is a great interindividual variability: gas evacuation in subjects maintained on a similar diet may differ substantially, and this depends on the composition and metabolic pathways of the colonic microbiota. Hence, the volume of gas production and anal evacuation is determined by two main factors: the diet, particularly the amount of fermentable residues, and the individual composition of colonic microbiota. 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 and may induce gas-related symptoms. However, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production and the initial symptoms disappear. Some data suggest that phenolic compounds have prebiòtic properties. Aim of the study: to explore the prebiotic effect of a combination of two polyphenol-rich berry extracts (cranberry and chokeberry). Design: single-centre, single arm, open label, proof-of-concept study in healthy subjects. Intervention: a combination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days. Outcomes: during 2 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Arms & Interventions

Healthy subjects

Experimental

Prebiotic administration

Intervention: Prebiotic (Dietary Supplement)

Outcomes

Primary Outcomes

Number of daily anal gas evacuations

Time Frame: 18 days

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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