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Clinical Trials/NCT03783260
NCT03783260CompletedNot Applicable

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

Laval University2 sites in 1 country21 target enrollmentStarted: January 7, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
2
Primary Endpoint
Microbiome-derived metabolite profiling

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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

  • Endocannabinoid interaction with interindividual microbiome composition(19 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alain Veilleux

Professor

Laval University

Study Sites (2)

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