Metabolomics Initiative: Mediterranean-amplified vs Habitual Western Diet on Food Signatures, Health, and Microbiome

Summary

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.

Conditions

• Dietary Habits

Interventions

OTHER

Semi-controlled dietary intervention - Western

Participants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Western diet foods (eg, beef, potatoes, bread, sour cream) provided during each intervention and will be repeated twice.

OTHER

Semi-controlled dietary intervention - MiniMed

Participants will complete a 2-week washout prior to a 16-week randomized, crossover semi-controlled feeding study of mini-MED vs Western diet. Each diet intervention will last four weeks, with 500 kcal/day of target Mediterranean foods (eg, oatmeal, salmon, nuts, basil, olive oil, fruits) provided during each intervention and will be repeated twice.

Sponsors & Collaborators

• University of Colorado, Denver

  lead OTHER

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

  collaborator NIH

• National Cattlemen's Beef Association

  collaborator INDUSTRY

• Purdue University

  collaborator OTHER

Principal Investigators

• Nancy F Krebs, MD · University of Colorado School of Medicine

• Nichole Reisdorph, PhD · University of Colorado School of Pharmacy

• Wayne Campbell, PhD · Purdue University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-21

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• United States

Study Locations