Clinical trial NCT05931237: Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
Official title: Evaluation of the Inter-individual Variability Associated With the Interaction Between Flavan-3-ols From Cranberry and Gut Microbiota - an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Symrise
First posted: 2023-07-05
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Consumption of (poly)phenols is recognized to have beneficial effects on health. However, heterogeneous results are obtained in clinical trials due to high inter-individual variability. The objective of this pilot study is to characterize the inter-individual variability associated with the interaction of (poly)phenols from cranberry and gut microbiota.

The participants (n=39) of this study are healthy adults aged between 23 and 63 years old and consumed cranberry extract rich in (poly)phenols for 4 days. Plasma, urine and feces were collected to quantify gut microbial (poly)phenols metabolites and to profile the fecal microbiota.


Eligibility criteria: Inclusion Criteria:

* Stable weight
* Stable or no medication
* Stable diet
* Stable physical activity

Exclusion Criteria:

* Pregnant women
* Antibiotic and/or probiotic use three months prior to the study
* Smokers

Primary outcomes:
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in gut microbial flavan-3-ols metabolites concentration in 24h urine before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in gut microbial flavan-3-ols metabolites concentration in plasma before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in gut microbial flavan-3-ols metabolites concentration in fecal samples before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
Secondary outcomes:
measure: Change in the gut microbiota composition before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline microbial composition at 4 days
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in short-chain fatty acids (SCFA) concentration in 24h urine before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline SCFA at 4 days
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in bile acids concentration in plasma before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline bile acids at 4 days
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in tryptophan metabolites concentration in fecal samples before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline tryptophan metabolites at 4 days
measure: Targeted metabolomic assessment (UPLC-QToF-MS) of the change in short-chain fatty acids (SCFA) concentration in the plasma before and after supplementation of a cranberry extract.
timeFrame: Change from Baseline SCFA at 4 days
measure: Determine the effect of a 4-day cranberry extract supplementation on the changes in bile acid concentration in fecal samples (UPLC-QToF-MS).
timeFrame: Change from Baseline bile acids at 4 days
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University
Study officials:
References: