Mediterranean Diet vs Western Diet for Healthy Eating Habits

(Mini-MED Trial)

Overseen By Nancy F Krebs, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Hyperglycemia, Hypertension, Hypercholesterolemia medications

Must not be taking: Warfarin

Disqualifiers: Crohn's, Celiac, Liver, Kidney, others

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

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This study plans to learn more about how consuming a diet with foods typical to a Mediterranean Diet such as whole grains, fruits and vegetables in a Western-style diet compares to eating a typical Western-style diet. This study will look at how diet affects overall health including risk factors for heart disease, gut health and inflammation as well as underlying mechanisms linking whole food to health. Findings from this study will potentially inform effective dietary recommendations and interventions, thereby reducing chronic disease in humans.

Research Team

Wayne Campbell, PhD

Principal Investigator

Purdue University

Nancy F Krebs, MD

Principal Investigator

University of Colorado School of Medicine

Nichole Reisdorph, PhD

Principal Investigator

University of Colorado School of Pharmacy

Eligibility Criteria

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.

Inclusion Criteria

I am between 30 and 69 years old.

Follows an omnivorous diet and willing to consume all provided foods

No plans to relocate or for extended travel (>1 week) within next 6 months

Exclusion Criteria

Food allergies to foods provided in either dietary intervention

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants undergo a 16-week randomized, cross-over, semi-controlled feeding study of two isocaloric dietary interventions: Mediterranean-amplified habitual/Western (mini-MED) diet and Habitual/Western (Western) diet.

16 weeks

Follow-up

Participants are monitored for changes in cardiometabolic health, microbiome structure/function, and metabolomics signatures after dietary interventions.

4 weeks

Treatment Details

Interventions

• Semi-controlled dietary intervention
• Semi-controlled dietary intervention - MiniMed
• Semi-controlled dietary intervention - Western

Trial Overview 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.

Participant Groups

Group I: mini-Med Experimental Treatment 1 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: Western Active Control 1 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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Cattlemen's Beef Association

Collaborator

Trials

26

Recruited

1,300+