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

NCT ID: NCT06765369

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mediterranean Diet

During the Mediterranean Diet (MD) phase, participants will receive three meals and two snacks per day for three weeks, adhering to the MD guidelines. To monitor compliance, participants will log their daily appetite and record any uneaten food. Additionally, participants will meet with the Research Coordinator weekly to receive guidance and support throughout the nutrition intervention.

Group Type: ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type: OTHER

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

During the Westernized Diet phase, participants will receive three meals and two snacks per day for three weeks, following a Westernized diet plan. To ensure compliance, participants will log their daily appetite and record any uneaten food. They will also meet with the Research Coordinator weekly for additional support and guidance.

Group Type: ACTIVE_COMPARATOR

Westernized Diet

Intervention Type: OTHER

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.

Washout Period

This will be the period between two different interventions where participants will consume their usual diet while we wait for the participants' microbes to normalize after the first intervention before beginning the next one.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Natasha Haskey

Research Associate, Department of Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natasha Haskey, RD PHD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Maitreyi Raman, MSc MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of British Columbia-Okanagan

Kelowna, British Columbia, Canada

Countries

Canada

Central Contacts

Natasha Haskey, PhD

Role: CONTACT

natasha.haskey@ubc.ca

250-807-9597

Maitreyi Raman, MD

Role: CONTACT

mkothand@ucalgary.ca

403-592-5020

Other Identifiers

POP23-11034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H24-01007

Identifier Type: -

Identifier Source: org_study_id