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

Official title

Predicting Microbiome-Associated Personalized Responses to the Mediterranean Diet

Overview

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.

Interventions

• 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 th
• 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 profil

Primary outcome measures

• Microbiome - Microbial Diversity [Time frame: Baseline, Week 3, Week 9 and Week 12]
• Microbiome - Microbial Signature [Time frame: Baseline, Week 3, Week 9 and Week 12]

Secondary outcome measures (7)

• Metabolomics - Change in fecal metabolites [Time frame: Baseline, Week 3, Week 9 and Week 12]
• Metabolomics - Change in serum metabolites [Time frame: Baseline, Week 3, Week 9 and Week 12]
• Change in Quality of Life [Time frame: Baseline, Week 3, Week 9, Week 12]
• Dietary intake [Time frame: Baseline, Week 9]
• Appetite rating [Time frame: 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.]
• Change in Anxiety [Time frame: Baseline, Week 3, Week 9 and Week 12]
• Change in Depression [Time frame: Baseline, Week 3, Week 9 and Week 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• University of British Columbia-Okanagan — Kelowna

Identifiers

NCT: NCT06765369 · H24-01007 · POP23-11034

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗