Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults

June 26, 2023 updated by: Yves Desjardins, Laval University

Evaluation of the Inter-individual Variability Associated With the Interaction Between Flavan-3-ols From Cranberry and Gut Microbiota - an Exploratory Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1v 0A6
        • Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cranberry extract capsules (PREBIOCRAN(TM))
Cranberry extract capsules consumed twice a day providing 82.3 mg of flavan-3-ols daily.
Dietary supplement: Cranberry extract capsules
Cranberry extract capsules (Prebiocran(TM))
Other Names:
  • Prebiocran cranberry extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
Determine the change in concentration of flavan-3-ols metabolites generated by the gut microbial metabolism before and after the consumption of 82.3 mg/day of cranberry extract in 24h urine samples (µmol/24h). The following microbial metabolites of flavan-3-ols will be determined by UPLC-QToF-MS: 5-(3´-hydroxyphenyl)-γ-valerolactone (3-HPVL), 5-(3´,4´-dihydroxyphenyl)-γ-valerolactone (3,4-DHPVL), 5-(3´-hydroxyphenyl)valeric acid (3-HPVA),and 5-(3´,4´-dihydroxyphenyl)valeric acid (3,4-DHPVA), 1-(3',4'-Dihydroxyphenyl)-3-(2",4",6"-trihydroxyphenyl)-propan-2-ol (3,4-DHPP-2-ol), 1-(3'-Hydroxyphenyl)-3-(2",4",6"-trihydroxyphenyl)-propan-2-ol (3-HPP-2-ol), 3-(3',4'-Dihydroxyphenyl)propanoic acid (3,4-DHPPA), and 3-(3'-Hydroxyphenyl)propanoic acid (3-HPPA).
Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
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.
Time Frame: Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
Determine the change in concentration of flavan-3-ols metabolites generated by the gut microbial metabolism before and after the consumption of 82.3 mg/day of cranberry extract in plasma samples (nmol/L). The following microbial metabolites of flavan-3-ols will be determined by UPLC-QToF-MS: 5-(3´-hydroxyphenyl)-γ-valerolactone (3-HPVL), 5-(3´,4´-dihydroxyphenyl)-γ-valerolactone (3,4-DHPVL), 5-(3´-hydroxyphenyl)valeric acid (3-HPVA),and 5-(3´,4´-dihydroxyphenyl)valeric acid (3,4-DHPVA), 1-(3',4'-Dihydroxyphenyl)-3-(2",4",6"-trihydroxyphenyl)-propan-2-ol (3,4-DHPP-2-ol), 1-(3'-Hydroxyphenyl)-3-(2",4",6"-trihydroxyphenyl)-propan-2-ol (3-HPP-2-ol), 3-(3',4'-Dihydroxyphenyl)propanoic acid (3,4-DHPPA), and 3-(3'-Hydroxyphenyl)propanoic acid (3-HPPA).
Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
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.
Time Frame: Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days
Determine the change in concentration of flavan-3-ols metabolites generated by the gut microbial metabolism before and after the consumption of 82.3 mg/day of cranberry extract in fecal samples (nmol/g). The following microbial metabolites of flavan-3-ols will be determined by UPLC-QToF-MS: 5-(3´-hydroxyphenyl)-γ-valerolactone (3-HPVL), 5-(3´,4´-dihydroxyphenyl)-γ-valerolactone (3,4-DHPVL), 5-(3´-hydroxyphenyl)valeric acid (3-HPVA),and 5-(3´,4´-dihydroxyphenyl)valeric acid (3,4-DHPVA), 1-(3',4'-Dihydroxyphenyl)-3-(2",4",6"-trihydroxyphenyl)-propan-2-ol (3,4-DHPP-2-ol), 1-(3'-Hydroxyphenyl)-3-(2",4",6"-trihydroxyphenyl)-propan-2-ol (3-HPP-2-ol), 3-(3',4'-Dihydroxyphenyl)propanoic acid (3,4-DHPPA), and 3-(3'-Hydroxyphenyl)propanoic acid (3-HPPA).
Change from Baseline concentration in flavan-3-ols gut metabolites at 4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the gut microbiota composition before and after supplementation of a cranberry extract.
Time Frame: Change from Baseline microbial composition at 4 days
Determine the effect of a 4-day supplementation of cranberry extract on the composition of the gut microbiota through 16S ribosomal ribonucleic acid (rRNA) sequencing. Evaluate the changes in composition of the major microbial families and genus of participants' fecal samples. Changes in microbiota functional profile will be assessed by comparing over and under-expressed Amplicon Sequence Variants (ASV) against the SILVA databased based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) Ontology (KO) functional and pathway profiles.
Change from Baseline microbial composition at 4 days
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.
Time Frame: Change from Baseline SCFA at 4 days
Determine the effect of a 4-day cranberry extract supplementation on the changes in concentration (nmol/24h) in SCFA (acetate, propionate, butyrate, valerate), in 24h urine samples (UPLC-QToF-MS).
Change from Baseline SCFA at 4 days
Targeted metabolomic assessment (UPLC-QToF-MS) of the change in bile acids concentration in plasma before and after supplementation of a cranberry extract.
Time Frame: Change from Baseline bile acids at 4 days
Determine the effect of a 4-day cranberry extract supplementation on the changes in bile acids (cholic acid, chenodeoxycholic acid, ursodeoxycholic acid, lithocholic) concentration in plasma samples (nmol/L) (UPLC-QToF-MS).
Change from Baseline bile acids at 4 days
Targeted metabolomic assessment (UPLC-QToF-MS) of the change in tryptophan metabolites concentration in fecal samples before and after supplementation of a cranberry extract.
Time Frame: Change from Baseline tryptophan metabolites at 4 days
Determine the effect of a 4-day cranberry extract supplementation on the changes in tryptophan metabolites (serotonin, kynurenine, tryptamine, quinolinic acid) concentration in fecal samples (nmol/g) (UPLC-QToF-MS).
Change from Baseline tryptophan metabolites at 4 days
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.
Time Frame: Change from Baseline SCFA at 4 days
Determine the effect of a 4-day cranberry extract supplementation on the changes in concentration (nmol/24h) in SCFA (acetate, propionate, butyrate, valerate), in plasma samples (nmol/L)(UPLC-QToF-MS).
Change from Baseline SCFA at 4 days
Determine the effect of a 4-day cranberry extract supplementation on the changes in bile acid concentration in fecal samples (UPLC-QToF-MS).
Time Frame: Change from Baseline bile acids at 4 days
Determine the effect of a 4-day cranberry extract supplementation on the changes in bile acids (cholic acid, chenodeoxycholic acid, ursodeoxycholic acid, lithocholic) concentration in fecal samples (nmol/g) (UPLC-QToF-MS).
Change from Baseline bile acids at 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Symrise

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Metacann

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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