CClinicalTrials.gg
CompletedNCT03783260METAUpdated Feb 28, 2020

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

An interventional study of Mediterranean diet in Food Habits, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Laval University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Food Habits

Keywords

  • Gut Microbiome
  • Metabolites
  • Endocannabinoid
  • Mediterranean diet
03

In context

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Single

    All participating subjects will undergo two, 2-day Mediterranean diet feeding periods separated by a 14-day period of Canadian diet

    Other: Mediterranean diet

Interventions

  • OtherMediterranean diet

    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.

06

What researchers measure

Primary outcomes

  1. Microbiome-derived metabolite profiling

    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.

    Time frame: 19 days

  2. Gut microbiome characterisation

    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.

    Time frame: 19 days

Secondary outcomes

  1. Endocannabinoid interaction with interindividual microbiome composition

    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.

    Time frame: 19 days

07

Study locations

1 site
  • Institut sur la nutrition et les aliments fonctionnels - INAF
    Québec, Quebec G1V 0A6, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03783260
Lead sponsor
Laval University
Responsible party
Alain Veilleux (Professor, Laval University) — Principal investigator
First posted
Dec 21, 2018
Start date
Jan 7, 2019
Primary completion
Apr 1, 2019
Completion
Dec 1, 2019
Last update
Feb 28, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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