HealthyMAP-MedNCT06765369
How the Mediterranean Diet Affects You: Predicting Responses Based on Your Microbiome
A study testing Mediterranean diet and Westernized Diet in people with Healthy, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mediterranean diet and Westernized Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of British Columbia-Okanagan
Kelowna, British Columbia, V1V 1V7
About this study
Official title: Predicting Microbiome-Associated Personalized Responses to the Mediterranean Diet
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:
Read more
- Are there specific microbes that influence who is most likely to benefit from the Mediterranean diet?
- 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.
Read the 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
- Being tested
- Mediterranean diet, Westernized Diet
- Keywords
- Healthy Individuals, Mediterranean diet, Westernized Diet, Predictive Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
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 DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 3, Week 9 and Week 12
Secondary outcomes (7)
Metabolomics - Change in fecal metabolites
Fecal metabolites will be analyzed using a untargeted metabolomic platform with samples collected pre and post MD and Western diet. Quantification will be performed using untargeted reverse-phase ultrahigh-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS).
Measured: Baseline, Week 3, Week 9 and Week 12
Metabolomics - Change in serum metabolites
Serum metabolites will be analyzed using a untargeted metabolomic platform with samples collected pre and post MD and Western diet. Quantification will be performed using untargeted reverse-phase ultrahigh-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS).
Measured: Baseline, Week 3, Week 9 and Week 12
Change in Quality of Life
Health-related quality of life will be measured using the 12-item short form-12 (SF-12). The SF-12 is comprised of two components: physical health and mental health. Scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Measured: Baseline, Week 3, Week 9, Week 12
Dietary intake
Dietary intake and supplement use will be evaluated at both baseline and week 9 using two non-consecutive 24-hour food recalls collected through the ASA-24 Canadian version. These assessments will establish participants' habitual dietary patterns and help monitor dietary consistency during the washout period.
Measured: Baseline, Week 9
Appetite rating
Visual Analog Scales (VAS) for Appetite will be used to assess appetite of healthy participants in response to interventions with Mediterranean and Western diets. Higher values typically indicate greater intensity of the sensation being measured.
Measured: 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
Anxiety will be assessed by the GAD-7 (Generalized Anxiety Disorder-7). It is a self-reported screening tool used to measure the severity of generalized anxiety disorder (GAD) symptoms over the past two weeks. The total score ranges from 0 to 21. A score of 10 or higher typically indicates clinically significant anxiety and suggests the need for further evaluation or intervention..
Measured: Baseline, Week 3, Week 9 and Week 12
Change in Depression
Depression levels will be assessed by PHQ-8 (Patient Health Questionnaire-8). It is a widely used self-report screening tool for assessing the severity of depressive symptoms over the past two weeks. The total score is the sum of all item responses, ranging from 0 to 24. A score of 10 or higher indicates the presence of clinically significant depressive symptoms and suggests the need for further evaluation or intervention.
Measured: Baseline, Week 3, Week 9 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start8 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Natasha Haskey, University of British Columbia
- Investigators
- Natasha Haskey, RD PHD, Principal investigator, University of British ColumbiaMaitreyi Raman, MSc MD FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765369
- Sponsor's protocol ID
- H24-01007
- Other IDs
- POP23-11034
- Acronym
- MAP-Med
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD used in the results of the publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Microbiome-Associated Personalized Responses to the Mediterranean Diet
- ClinicalTrials.gov ID
- NCT06765369
- Acronym / sponsor ID
- MAP-Med / H24-01007
- Conditions
- Healthy
- Keywords
- Healthy Individuals, Mediterranean diet, Westernized Diet, Predictive Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are there specific microbes that influence who is most likely to benefit from the Mediterranean diet?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Active comparator | Other: Mediterranean dietDuring 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. |
| Westernized Diet | Active comparator | Other: Westernized DietDuring 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. |
| 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietThe 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) | Other | Mediterranean Diet |
| Westernized DietThe 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. | Other | Westernized Diet |
Primary outcome
Microbiome - Microbial Diversity
Time frame: Baseline, Week 3, Week 9 and Week 12
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.
Microbiome - Microbial Signature
Time frame: Baseline, Week 3, Week 9 and Week 12
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Yes. All IPD used in the results of the publication will be shared
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natasha Haskey, RD PHD principal investigator
University of British Columbia
Maitreyi Raman, MSc MD FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Westernized Diet in people with Healthy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Haskey, PhD (250-807-9597, natasha.haskey@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome - Microbial Diversity (time frame: Baseline, Week 3, Week 9 and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.