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Mediterranean Diet vs Western Diet for Healthy Eating Habits (Mini-MED Trial)
N/A
Waitlist Available
Led By Nichole Reisdorph, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to endline changes over each 4-week dietary intervention period
Awards & highlights
No Placebo-Only Group
Summary
This trial compares the health benefits of a Mediterranean-style diet of whole grains, fruits and veggies to a typical Western-style diet. Results could inform dietary recommendations to reduce chronic diseases.
Who is the study for?
This trial is for adults aged 30-69 with overweight or obesity, stable weight, and at least three signs of Metabolic Syndrome. Participants must be nonsmokers, maintain consistent physical activity, eat an omnivorous diet not aligned with the Mediterranean style, and agree to biweekly clinic visits. Exclusions include vegetarians/vegans, certain medication users (e.g., warfarin), those with conditions affecting food metabolism (like Crohn's disease), pregnant/lactating women, or anyone planning extended travel.
What is being tested?
The study compares the effects of a Mediterranean-amplified diet versus a typical Western diet on health markers like heart disease risk factors and gut health. It will assess how these diets influence inflammation and metabolomics profiles to inform dietary recommendations aimed at reducing chronic diseases.
What are the potential side effects?
Since this is a dietary intervention study focusing on normal foods rather than medications or supplements, significant side effects are not anticipated. However, changes in diet may cause temporary digestive discomfort as the body adjusts to new eating habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to endline changes over each 4-week dietary intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to endline changes over each 4-week dietary intervention period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Foodomics
Secondary study objectives
Cardiometabolic Health - Adipokines
Cardiometabolic Health - Blood Pressure
Cardiometabolic Health - C-reactive protein
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mini-MedExperimental Treatment1 Intervention
Mediterranean-amplified habitual/Western (mini-MED) diet, containing 500 kcal/day from Mediterranean target foods (such as raspberries, avocado, red bell pepper, basil, walnuts, chickpeas, oats, salmon).
Group II: WesternActive Control1 Intervention
Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert).
Find a Location
Who is running the clinical trial?
Purdue UniversityOTHER
233 Previous Clinical Trials
71,351 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,277 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,086 Total Patients Enrolled
National Cattlemen's Beef AssociationOTHER
25 Previous Clinical Trials
1,227 Total Patients Enrolled
Nichole Reisdorph, PhDPrincipal InvestigatorUniversity of Colorado School of Pharmacy
Wayne Campbell, PhDPrincipal InvestigatorPurdue University
4 Previous Clinical Trials
111 Total Patients Enrolled
Nancy F Krebs, MDPrincipal InvestigatorUniversity of Colorado School of Medicine
2 Previous Clinical Trials
107 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 69 years old.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have a condition that affects my appetite, how I eat, or how my body uses food.I have at least three symptoms of Metabolic Syndrome or am on medication for high blood sugar, high blood pressure, or high cholesterol.My liver or kidney is not working properly.My BMI is between 25-37 and my weight has been stable.My medications have been the same for the last 6 months and will not change during the study.I am willing to stop taking any supplements not prescribed by my doctor during the study.I am willing and able to agree to the study's procedures.I am not on medications like warfarin that limit eating more fruits/vegetables.I am willing to visit the clinic every two weeks for check-ups and tests.
Research Study Groups:
This trial has the following groups:- Group 1: mini-Med
- Group 2: Western
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.