Healthy
Conditions
Keywords
intestinal gas, healthy subjects, microbiota, prebiotics
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic
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.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
\-
Exclusion criteria
* gastrointestinal symptoms * recent (3 months) antibiotic intake * change in dietary habits 4 weeks before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Microbiota composition by fecal analysis | 18 days | Change from beginning of treatment to end of treatment |
| 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 |
| 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. |
| 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 |
Countries
Spain
Outcome results
None listed