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

NCT06765369 | Not Yet Recruiting DMC

• 2 other identifiers: H24-01007POP23-11034
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Healthy Individuals; Mediterranean diet; Westernized Diet; Predictive Microbiome

Outcome Measures

Primary Outcomes (2)

• Microbiome - Microbial Diversity

  Metagenomic sequencing will be employed to analyze stool samples, focusing on changes in the taxonomic composition of the gut microbiome in healthy individuals in response to interventions with the Mediterranean and Western diets.

  Baseline, Week 3, Week 9 and Week 12

• Microbiome - Microbial Signature

  Metagenomic sequencing will be utilized to analyze stool samples, aiming to identify microbial signatures of the gut microbiome in healthy individuals following interventions with the Mediterranean and Western diets.

  Baseline, Week 3, Week 9 and Week 12

Secondary Outcomes (7)

• Metabolomics - Change in fecal metabolites

  Baseline, Week 3, Week 9 and Week 12

• Metabolomics - Change in serum metabolites

  Baseline, Week 3, Week 9 and Week 12

• Change in Quality of Life

  Baseline, Week 3, Week 9, Week 12

• Dietary intake

  Baseline, Week 9

• Appetite rating

  The Visual Analog Scales (VAS) for Appetite will be completed daily throughout the dietary intervention period, which includes 3 weeks on the Mediterranean diet and 3 weeks on the Western diet.

Study Arms (3)

Mediterranean Diet

ACTIVE COMPARATOR

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.

Other: Mediterranean diet

Westernized Diet

ACTIVE COMPARATOR

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.

Other: Westernized Diet

Washout Period

NO INTERVENTION

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.

Interventions

Mediterranean diet 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)

Mediterranean Diet

Westernized Diet 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.

Westernized Diet

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• University of Calgary: collaborator

Study Sites (1)

University of British Columbia-Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Interventions

Diet, Mediterranean

Intervention Hierarchy (Ancestors)

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

Study Officials

• Natasha Haskey, RD PHD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Maitreyi Raman, MSc MD FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Haskey, PhD

CONTACT

250-807-9597; natasha.haskey@ubc.ca

Maitreyi Raman, MD

CONTACT

403-592-5020; mkothand@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate, Department of Biology

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: January 8, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From December 31, 2026 onward
• Access Criteria: A proposal for planned analyses must be submitted to the PI's of this research.

Locations

CA (1)