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

NCT03783260 | Completed

• 1 other identifier: 2018-262
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Habits

Keywords

Gut Microbiome; Metabolites; Endocannabinoid; Mediterranean diet

Outcome Measures

Primary Outcomes (2)

• 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.

  19 days

• 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.

  19 days

Secondary Outcomes (1)

• Endocannabinoid interaction with interindividual microbiome composition

  19 days

Study Arms (1)

Single

EXPERIMENTAL

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

Mediterranean diet 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.

Single

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels - INAF

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 21, 2018
• Study Start: January 7, 2019
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

CA (1)