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ACTIVE NOT RECRUITING

NCT05500976

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

Official title: Metabolomics INItiative: Effects of a MEDiterranean-amplified vs Habitual Western Diet on Biomarker Signatures, Cardiometabolic Health, and the Microbiome

Key Details

Gender

All

Age Range

30 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-11-21

Completion Date

2025-03-31

Last Updated

2024-08-27

Healthy Volunteers

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.

Inclusion Criteria: * Overweight or obesity (BMI 25-37 kg/m2) and weight-stable; * Age 30-69 years; * Nonsmoker (including tobacco, marijuana, and other inhaled substances); * Consistent physical activity levels for 3 months prior to and throughout the study period; * Stable medication use for 6 months prior to and throughout the study period; * Having at least three components of Metabolic Syndrome (MetS): i.e., impaired fasting glucose, hypertension, central adiposity (waist circumference ≥ 94 cm or 80 cm, for men and women, respectively), fasting hypertriglyceridemia, and/or low levels of HDL cholesterol17 OR on medication for the treatment of hyperglycemia, hypertension, or hypercholesterolemia in lieu of meeting the corresponding MetS component; * Report of baseline consumption of a habitual diet not meeting criteria for a Mediterranean-style dietary pattern, defined as a score of \<5 as assessed via the Mediterranean Diet Assessment Tool * Follows an omnivorous diet and willing to consume all provided foods (e.g., will eat salmon, fruits/vegetables, beef); * Willingness to refrain from consumption of nutritional supplements, herbal supplements, botanical supplements, and pre- or probiotics aside from those prescribed by a physician for the duration of the study; * Willingness to come to the CTRC biweekly for clinical assessments and biospecimen collection; * No plans to relocate or for extended travel (\>1 week) within next 6 months; and * Capable and willing to provide informed consent Exclusion Criteria: * Use of medications contraindicating increased consumption of fruits/vegetables (e.g., warfarin); * Diagnosis of acute or chronic condition impacting appetite, food intake, and/or the metabolism and absorption of foods to be provided (e.g., Crohn's disease, Celiac disease, Ulcerative colitis, short bowel syndrome, chronic diarrhea); * Impaired liver or kidney function; * Food allergies to foods provided in either dietary intervention; * Vegetarian, vegan; and * For females: pregnant or lactating or planning to become pregnant during study period

Locations (1)

University of Colorado School of Medicine

Aurora, Colorado, United States