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

Sponsor

Laval University (Other)

Overall Status

Completed

CT.gov ID

NCT03783260

Collaborator

(none)

Enrollment

Location

Arm

10.8

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Food Habits	Other: Mediterranean diet	N/A

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

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 7, 2019

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Microbiome-derived metabolite profiling [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 [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 Outcome Measures

Endocannabinoid interaction with interindividual microbiome composition [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut sur la nutrition et les aliments fonctionnels - INAF	Québec	Quebec	Canada	G1V 0A6

Sponsors and Collaborators

Laval University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alain Veilleux, Professor, Laval University

ClinicalTrials.gov Identifier:

NCT03783260

Other Study ID Numbers:

2018-262

First Posted:

Dec 21, 2018

Last Update Posted:

Feb 28, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alain Veilleux, Professor, Laval University

Study Results

No Results Posted as of Feb 28, 2020