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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to endline changes over each 4-week dietary intervention period for reporting.

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 more

Awards & 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).

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