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

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT05931237
Collaborator
Symrise (Other)
39
1
1
2.3
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Cranberry extract capsules
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Evaluation of the Inter-individual Variability Associated With the Interaction Between Flavan-3-ols From Cranberry and Gut Microbiota - an Exploratory Study
Actual Study Start Date :
Sep 9, 2021
Actual Primary Completion Date :
Nov 19, 2021
Actual Study Completion Date :
Nov 19, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [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).

    2. 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. [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).

    3. 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. [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).

    Secondary Outcome Measures

    1. Change in the gut microbiota composition before and after supplementation of a cranberry extract. [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.

    2. 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. [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).

    3. Targeted metabolomic assessment (UPLC-QToF-MS) of the change in bile acids concentration in plasma before and after supplementation of a cranberry extract. [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).

    4. Targeted metabolomic assessment (UPLC-QToF-MS) of the change in tryptophan metabolites concentration in fecal samples before and after supplementation of a cranberry extract. [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).

    5. 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. [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).

    6. Determine the effect of a 4-day cranberry extract supplementation on the changes in bile acid concentration in fecal samples (UPLC-QToF-MS). [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laval University Québec Canada G1V 0A6

    Sponsors and Collaborators

    • Laval University
    • Symrise

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yves Desjardins, Full professor, Laval University
    ClinicalTrials.gov Identifier:
    NCT05931237
    Other Study ID Numbers:
    • Metacann
    First Posted:
    Jul 5, 2023
    Last Update Posted:
    Jul 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 5, 2023