NCT06765369

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

Predicting Microbiome-Associated Personalized Responses to the Mediterranean Diet

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Understanding the role of therapeutic dietary interventions in treating chronic diseases requires acknowledging that the response to nutrition varies in populations, subgroups and individual's. Varying responses to dietary intervention is dependent on interpersonal differences and environment. Personalized nutrition addresses these differences between individuals to maximize the benefits of dietary interventions. Many large, randomized controlled trials have effectively demonstrated that only 40% of a study cohort responds to dietary interventions, and lifestyle measures in regards to reducing disease risk. A more pragmatic approach to enhance the effectiveness of dietary treatment emerges by identifying microbiome-derived biomarkers capable of predicting and categorizing those most likely to benefit from specific nutritional interventions. Developing a predictive microbiome signature represents an advancement in this endeavour, offering the prospect of tailored, personalized nutrition interventions and a comprehensive understanding of the intricate interplay between diet, gut microbiota composition, and human health. Specifically, the Mediterranean diet (MD) has been investigated as a therapeutic diet for varying diseases due to its positive correlation with an array of health benefits. However, there is little consensus on specific microbial changes associated with the MD and how the MD alters the gut microbiome. This study aims to fill this knowledge gap that exists surrounding the MD and to determine a predictive microbiome associated with the MD. Ultimately producing a highly predictive microbiome signature that will have the ability to identifies those who will respond to the MD.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	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)
OTHER	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.

Timeline

• Start date: 2025-01-08
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: Canada