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Completed

NCT Number: NCT03783260

Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet

This project proposes to characterise the microbiome-derived metabolites produced upon ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the relationship between gut microbiome composition and the nature of dietary metabolites production.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut sur la nutrition et les aliments fonctionnels - INAF

Québec, Quebec, G1V 0A6, Canada

About this study

There is a large inter-individual variability in gut microbiome-derived metabolites production upon ingestion of similar meals. Since many of these microbiome-derived metabolites have enteric and systemic biological effects, these variabilities could in part account for the different responses to meals and diets.

This project thus aims to improve the understanding the relationship between gut microbiome composition and the nature of dietary metabolites produced from similar bioactive precursor-rich meals.

The investigators therefore propose to characterise the circulating microbiome-derived metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean diet prior to and after a 2-week of habitual Canadian diet feeding.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women aged between 18 and 35 years
  • Body mass index between 18.5 and 30 kg/m2
  • General good health
  • Computer and Internet access
  • Basic understanding of written French

Exclusion criteria

  • Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers
  • Pregnant and/or breast-feeding women
  • Alcohol consumption greater than 15 portions for men and 10 for women weekly
  • Active tobacco usage
  • Consumption of dietary supplements (e.g. multivitamins, omega-3, probiotics)
  • Completion of a course of antibiotics in the past 3 months
  • Regular use of anti-inflammatory drugs, or use in the past 3 months
  • Important weight change (+/- 5 kg) in the past 6 months
  • Allergies or food intolerances to ingredients present in trial diets

Treatment and study plan

Mediterranean Diet

Other

During both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided.

Primary outcomes

  1. Microbiome-derived metabolite profiling

    Time frame: 19 days

    Plasma and urine metabolomics profiling of gut-microbiome derived metabolites (e.g., branched-chain amino acids [BCAA], short chain fatty acids [SCFA], trimethylamine [TMA], amino acids- and polyphenol-metabolites) will also performed at the same time points.

  2. Gut microbiome characterisation

    Time frame: 19 days

    Fecal microbiome composition will be characterise by rRNA 16S sequencing prior to and following both 2-day Mediterranean diet periods. Relevant indexes of microbiome diversity (e.g. Shannon beta-diversity), ratios between meaningful bacterial markers of gut dysbiosis (e.g. Firmicutes:Bacteroidetes) and specific microbiome differences in bacterial Families, Genera or species between study periods and individuals.

Secondary outcomes

  1. Endocannabinoid interaction with interindividual microbiome composition

    Time frame: 19 days

    Interindividual variations in the endocannabinoid levels following a 2-day Mediterranean diet intervention according to individual gut microbiome composition will also be characterised. N-acyl ethanolamines, acylglycerols and omega-3 derived endocannabinoids will be quantified by LC MS-MS in plasma and urine samples collected prior to and following both 2-day Mediterranean diet periods.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: META

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Feb 28, 2020

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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