Mediterranean Diet for Healthy Subjects

(MAP-Med Trial)

Overseen By Maitreyi Raman, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Oral antibiotics

Disqualifiers: Irritable bowel syndrome, Diabetes, Food allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is the Mediterranean Diet safe for humans?

The Mediterranean Diet is generally considered safe for humans and has been associated with health benefits, particularly for heart health, due to its anti-inflammatory and antioxidant properties. ^{1 2 3 4 5}

How does the Mediterranean Diet treatment differ from other treatments for healthy subjects?

The Mediterranean Diet is unique because it emphasizes high consumption of plant-based foods, olive oil, and fish, with moderate wine intake, which collectively offer anti-inflammatory and antioxidant benefits. Unlike other treatments, it is a lifestyle-based approach that has been shown to improve heart health and reduce the risk of chronic diseases through its specific dietary pattern. ^{3 6 7 8 9}

What data supports the effectiveness of the Mediterranean Diet treatment?

Research shows that the Mediterranean Diet can reduce the risk of heart disease and cancer, and improve life expectancy, especially in older adults. Its benefits are linked to its anti-inflammatory and antioxidant properties, as well as its ability to help control weight. ^{3 10 11 12 13}

Who Is on the Research Team?

Natasha Haskey, RD PHD

Principal Investigator

University of British Columbia

Maitreyi Raman, MSc MD FRCPC

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in how diet affects their body, specifically through the gut microbiome. Participants will be provided with all meals and snacks to ensure a controlled study environment.

Inclusion Criteria

Must live in the Okanagan area

I am free from heart disease, diabetes, and high blood pressure.

Body Mass Index of 20-25

Exclusion Criteria

Individuals with any known food allergies, reported dietary intolerances of any kind, and those with eating disorders

My diet is high in Mediterranean foods.

Individuals who are intermittent fasting or refuse to follow the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mediterranean Diet

Participants receive three meals and two snacks per day for three weeks, adhering to the Mediterranean Diet guidelines. Compliance is monitored through daily appetite logs and weekly meetings with the Research Coordinator.

3 weeks

3 visits (in-person)

Washout Period

Participants consume their usual diet to allow their microbiome to normalize before the next intervention.

3 weeks

Westernized Diet

Participants receive three meals and two snacks per day for three weeks, following a Westernized diet plan. Compliance is monitored through daily appetite logs and weekly meetings with the Research Coordinator.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in microbiome, depression, anxiety, and quality of life after dietary interventions.

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet
• Westernized Diet

Trial Overview Researchers are testing whether specific microbes predict who benefits from a Mediterranean diet compared to a Westernized diet. The study provides all food and monitors changes in participants' gut microbiomes.

How Is the Trial Designed?

Group I: Mediterranean Diet Active Control 1 Intervention

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 II: Westernized Diet Active Control 1 Intervention

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 III: Washout Period Active Control 1 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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Published Research Related to This Trial

The Mediterranean Diet (MedDiet) has been linked to numerous health benefits, particularly in reducing the risk of cardiovascular diseases, metabolic disorders, and cancer, as evidenced by an increase in clinical trials over the last decade.

The diet's positive effects are largely attributed to its anti-inflammatory and antioxidant properties, with strict adherence and specific components like olive oil playing crucial roles in managing obesity and waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. Finicelli, M., Di Salle, A., Galderisi, U., et al.[2022]

Adherence to the Mediterranean Diet (MD) is linked to a lower incidence of cardiovascular and cerebrovascular events, with a significant reduction in risk observed as adherence increases, particularly in northern European participants.

In a study of 3703 individuals over 36 months, those with a higher MD score (≥4) experienced fewer vascular events compared to those with lower scores (0-1), suggesting that dietary changes can effectively reduce health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A priori-defined Mediterranean-like dietary pattern predicts cardiovascular events better in north Europe than in Mediterranean countries. Veglia, F., Baldassarre, D., de Faire, U., et al.[2023]

The German version of the Mediterranean Diet Adherence Screener (MEDAS) was validated in a study involving 68 women with BRCA1/2 mutations, showing high concordance with a full-length Food Frequency Questionnaire, indicating its reliability for assessing adherence to the Mediterranean Diet.

Participants who adhered more closely to the Mediterranean Diet, as measured by MEDAS, demonstrated significant associations with beneficial dietary biomarkers, such as higher omega-3 and lower omega-6 fatty acid levels, suggesting potential health benefits from the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Hebestreit, K., Yahiaoui-Doktor, M., Engel, C., et al.[2019]

This study will evaluate the cardiovascular and cognitive benefits of a modified Mediterranean diet that includes 2-3 servings of fresh, lean pork per week, aiming to make the diet more sustainable for Australian populations.

The trial will involve a 24-week cross-over design with at-risk men and women, measuring various health outcomes such as blood pressure, body composition, and cognitive function, which could provide important insights for preventing cardiovascular disease and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function. Wade, AT., Davis, CR., Dyer, KA., et al.[2019]

A Mediterranean diet supplemented with dairy foods significantly reduced systolic and diastolic blood pressure in participants at risk of cardiovascular disease, indicating improved cardiovascular health.

The MedDairy diet also led to favorable changes in cholesterol levels, including higher HDL cholesterol and lower triglycerides, suggesting it may be an effective dietary approach for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. Wade, AT., Davis, CR., Dyer, KA., et al.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mediterranean diet and age with respect to overall survival in institutionalized, nonsmoking elderly people. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A priori-defined Mediterranean-like dietary pattern predicts cardiovascular events better in north Europe than in Mediterranean countries. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Definitions and potential health benefits of the Mediterranean diet: views from experts around the world. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet and non-fatal acute myocardial infarction: a case-control study from Italy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Mediterranean diet and cardiovascular disease: a systematic review and meta-analysis of observational studies. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

"Towards an even healthier Mediterranean diet". [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

Atherosclerosis--epidemiological studies on the health effects of a Mediterranean diet. [2009]

12. Italy pubmed.ncbi.nlm.nih.gov

[Mediterranean diet and prevention of non-communicable diseases: scientific evidences]. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet and Cancer: What Do Human and Molecular Studies Have to Say about It? [2023]