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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03783260
Acronym
META
Enrollment
21
Registered
2018-12-21
Start date
2019-01-07
Completion date
2019-12-01
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Habits

Keywords

Gut Microbiome, Metabolites, Endocannabinoid, Mediterranean diet

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.

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.

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Microbiome-derived metabolite profiling19 daysPlasma 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 characterisation19 daysFecal 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

MeasureTime frameDescription
Endocannabinoid interaction with interindividual microbiome composition19 daysInterindividual 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026