Clinical trial NCT06765369: How the Mediterranean Diet Affects You: Predicting Responses Based on Your Microbiome
Official title: Predicting Microbiome-Associated Personalized Responses to the Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Healthy Individuals
Mediterranean diet
Westernized Diet
Predictive Microbiome
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2025-01-09
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Microbiome - Microbial Diversity
timeFrame: Baseline, Week 3, Week 9 and Week 12
measure: Microbiome - Microbial Signature
timeFrame: Baseline, Week 3, Week 9 and Week 12
Secondary outcomes:
measure: Metabolomics - Change in fecal metabolites
timeFrame: Baseline, Week 3, Week 9 and Week 12
measure: Metabolomics - Change in serum metabolites
timeFrame: Baseline, Week 3, Week 9 and Week 12
measure: Change in Quality of Life
timeFrame: Baseline, Week 3, Week 9, Week 12
measure: Dietary intake
timeFrame: Baseline, Week 9
measure: Appetite rating
timeFrame: 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.
measure: Change in Anxiety
timeFrame: Baseline, Week 3, Week 9 and Week 12
measure: Change in Depression
timeFrame: Baseline, Week 3, Week 9 and Week 12
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia-Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Natasha Haskey, RD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Maitreyi Raman, MSc MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: