Clinical Trials in Canada / NCT06765369
Starting soon Not applicable

How the Mediterranean Diet Affects You: Predicting Responses Based on Your Microbiome

NCT06765369 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-01-08
Last updated
2025-01-09

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Mediterranean dietWesternized Diet

Mediterranean diet: The MD is characterized by increased consumption of legumes, whole grains, vegetables, fruits, nuts, seeds and olive oil, moderate consumption of fish, poultry and dairy foods, with low consumption of processed foods and red meat. The nutritional profile of the MD intervention will consist of 46% carbohydrates, 17% protein, and 35% fat. A significant focus on dietary fat consumption with maintaining an omega 6:3 ratio of approximately 3:1 or lower. The MD will provide fibre-rich foods to meet the fibre recommendations for Canadians (males: 30 grams/day, females: 21 grams/day)

Westernized Diet: The WD is characterized by increased consumption of highly processed foods, refined grains, red meats, processed meats, added sugars, added salt, high intake of omega-6 PUFA, accompanied by a reduction in fibre, fruits and vegetables, whole grains, fish, as well as nuts and seeds.The nutrition composition of the WD intervention will consist of 46% of calories derived from refined carbohydrates and added sugars, 17% protein (sourced from red and processed meats) and 35% fat. The fatty acid profile will be characterized by higher amounts of n-6 PUFAs while lacking in n-3 PUFAs and MUFAs, with a omega 6:3 ratio of 15-20:1.

Study summary

People respond differently to various diets-some may see significant benefits, while others may not. This project aims to personalize dietary recommendations by analyzing the gut microbiome to predict who will benefit most from the Mediterranean diet based on their unique biology, including their microbiome.

The study focuses on answering these key questions:

1. Are there specific microbes that influence who is most likely to benefit from the Mediterranean diet?
2. What changes occur in the gut microbiome when healthy individuals follow a Mediterranean diet?

To explore these questions, researchers will compare the effects of a Mediterranean diet to a Western-style diet. Participants will receive all their meals and snacks for the study to ensure accurate comparisons of how these diets impact the gut microbiome.

Eligibility

Sex
ALL
Min age
20 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy participants, defined as free from cardiovascular disease, diabetes, and hypertension * Body Mass Index of 20-25 * Between the ages 20-50 years * Low adherence to the Mediterranean diet (MD serving score \[MDSS\] less than 10 points). * Must live in the Okanagan area Exclusion Criteria: * Individuals with a self-reported history of irritable bowel syndrome, inflammatory bowel disease, Type-2 diabetes, kidney disease, intestinal obstruction, infectious gastroenteritis, colitis or gastritis, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), malabsorption (such as celiac disease), major surgery of the GI tract, or colorectal cancer * Oral antibiotics within three months of the intervention start date * Individuals with any known food allergies, reported dietary intolerances of any kind, and those with eating disorders * Pregnant or breastfeeding * Participants with a high MDSS (\> 10 points) * Individuals who are intermittent fasting or refuse to follow the study protocol

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of British Columbia-Okanagan Kelowna British Columbia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06765369 on ClinicalTrials.gov ↗ ← All trials in Canada