Mediterranean Diet vs Western Diet for Healthy Eating Habits

(Mini-MED Trial)

JW
NF
Overseen ByNancy F Krebs, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Must be taking: Hyperglycemia, Hypertension, Hypercholesterolemia medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a Mediterranean-style diet with a Western diet in terms of overall health, focusing on heart disease risk, gut health, and inflammation. Participants will follow either a Mediterranean-enhanced diet or a typical Western diet. The researchers aim to assess how these diets affect health and potentially guide future dietary recommendations. Individuals who are overweight or obese, engage in consistent physical activity, and show signs of metabolic syndrome (such as high blood pressure or high cholesterol) may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could influence future dietary guidelines.

Will I have to stop taking my current medications?

The trial requires that you continue taking your current medications if they have been stable for 6 months prior to and throughout the study. However, you must avoid medications that conflict with increased fruit and vegetable intake, like warfarin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Mediterranean diet is generally safe. Studies have found it improves heart health by reducing risks such as high cholesterol and high blood pressure. It is also considered safe for individuals with serious kidney issues.

In contrast, the Western diet raises concerns. Research links it to a higher risk of heart disease, obesity, and diabetes. Consuming large amounts of fatty and sugary foods can also affect learning and memory.

In summary, the Mediterranean diet is well-tolerated and associated with positive health benefits, while the Western diet carries notable risks.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different diets impact healthy eating habits, focusing on a Mediterranean-amplified diet compared to a Western diet. Unlike the typical Western diet, which is rich in processed foods and red meats, the mini-MED diet incorporates Mediterranean target foods like salmon, walnuts, and chickpeas, which are known for their heart-healthy benefits. The trial aims to uncover if integrating Mediterranean foods into everyday meals can effectively improve dietary habits and overall health, potentially offering a simple, diet-based strategy for enhancing wellness.

What evidence suggests that this trial's dietary interventions could be effective for improving overall health?

This trial will compare the effects of a Mediterranean-amplified habitual/Western (mini-MED) diet with a habitual/Western diet. Research has shown that the Mediterranean Diet can significantly improve heart health. Studies have found it can lower the risk of dying from heart disease by up to 67% and reduce the chances of non-fatal heart problems. This diet is also linked to weight loss and better body weight compared to other diets. Additionally, the Mediterranean Diet is associated with a lower risk of developing several long-term diseases and may reduce the risk of dying from any cause by 23%. These findings suggest that eating Mediterranean foods can boost overall health and reduce the risk of chronic diseases.26789

Who Is on the Research Team?

WC

Wayne Campbell, PhD

Principal Investigator

Purdue University

NF

Nancy F Krebs, MD

Principal Investigator

University of Colorado School of Medicine

NR

Nichole Reisdorph, PhD

Principal Investigator

University of Colorado School of Pharmacy

Are You a Good Fit for This Trial?

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
See 9 more

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: mini-MedExperimental Treatment1 Intervention
Group II: WesternActive Control1 Intervention

Find a Clinic Near You

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 Cattlemen's Beef Association

Industry Sponsor

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Industry Sponsor

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+

Citations

The effectiveness of the Mediterranean Diet for primary and ...This review showed that the Mediterranean Diet can reduce fatal cardiovascular disease outcome risk by 10%–67% and non‐fatal cardiovascular disease outcome ...
Mediterranean diet in the management and prevention of ...The meta-analyses on RCTs showed a greater reduction of body weight and BMI with MedDiet compared to other diets and the meta-analysis on cohort studies showed ...
Mediterranean diet for heart healthMore-recent studies linked the Mediterranean diet with lower risk factors for heart disease, such as high cholesterol and high blood pressure. ...
Health Benefits of the Mediterranean Diet: Metabolic and ...Consuming a Mediterranean diet rich in minimally processed plant foods has been associated with a reduced risk of developing multiple chronic diseases and ...
Mediterranean Diet Adherence and Risk of All-Cause ...In this cohort study, higher adherence to the Mediterranean diet was associated with 23% lower risk of all-cause mortality.
The Mediterranean Diet: An Update of the Clinical Trials - PMCConcerning diets, several studies have shown the MedDiet's beneficial effect on preventing and controlling many metabolic problems, such as ...
Benefits and Harms of the Mediterranean Diet Compared to ...For secondary prevention, data from two trials indicate that assignment to a Mediterranean diet reduces incidence of myocardial infarction, but not other ...
Safety and impact of the Mediterranean diet in patients with ...These results indicate that the MEDi-POB diet is safe even in patients with advanced CKD, as it does not adversely affect serum and urine potassium levels and ...
Long-term outcomes of a Mediterranean diet with or ...Lastly, we hypothesized that the greatest cognitive improvements from baseline to 14 months and eight months to 14 months would be in the Med Diet plus weight ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security