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Completed

NCT Number: NCT05931237

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

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.

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Key information

Conditions

Healthy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laval University

Québec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry extract capsules

Dietary Supplement

Cranberry extract capsules (Prebiocran(TM))

Other names: Prebiocran cranberry extract

Primary outcomes

  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.

    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).

  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.

    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).

  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.

    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).

Secondary outcomes

  1. 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.

  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.

    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).

  3. 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).

  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.

    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).

  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.

    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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Symrise

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 5, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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