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

NCT ID: NCT03783260

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-12-01

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.

Conditions

Food Habits

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single

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

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Alain Veilleux

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut sur la nutrition et les aliments fonctionnels - INAF

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

2018-262

Identifier Type: -

Identifier Source: org_study_id