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

NCT05500976 | Active Not Recruiting

• 3 other identifiers: 21-4563R01DK1139572070
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mediterranean diet; Foodomics; Metabolomics; Food-specific signatures; Cardiometabolic health; Microbiome

Outcome Measures

Primary Outcomes (1)

• Foodomics

  Change in the number of unique to food compounds (i.e., putative biomarkers of intake) from baseline to end of each diet intervention period in participant serum samples.

  Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period

Secondary Outcomes (13)

• Cardiometabolic Health - IL-6

  Baseline to endline changes over each 4-week dietary intervention period

• Cardiometabolic Health - TNF-alpha

  Baseline to endline changes over each 4-week dietary intervention period

• Cardiometabolic Health - C-reactive protein

  Baseline to endline changes over each 4-week dietary intervention period

• Cardiometabolic Health - alpha-1-acid glycoprotein

  Baseline to endline changes over each 4-week dietary intervention period

• Cardiometabolic Health - Total Cholesterol

  Baseline to endline changes over each 4-week dietary intervention period

Study Arms (2)

mini-Med

EXPERIMENTAL

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).

Other: Semi-controlled dietary intervention - MiniMed

Western

ACTIVE COMPARATOR

Habitual/Western (Western) diet, containing 500 kcal/day from non-Mediterranean target foods (such as potato, beef, sour cream, refined grain bread, chocolate dessert).

Other: Semi-controlled dietary intervention - Western

Interventions

Semi-controlled dietary intervention - Western OTHER

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.

Western

Semi-controlled dietary intervention - MiniMed OTHER

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.

mini-Med

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator
• Purdue University: collaborator

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Hill EB, Tang M, Long JM, Kemp JF, Westcott JL, Hendricks AE, Reisdorph NA, Campbell WW, Krebs NF; mini-MED Trial Team. mini-MED: study protocol for a randomized, multi-intervention, semi-controlled feeding trial of a Mediterranean-amplified vs. habitual Western dietary pattern for the evaluation of food-specific compounds and cardiometabolic health. Trials. 2024 Feb 2;25(1):101. doi: 10.1186/s13063-024-07939-8.

  PMID: 38302990 DERIVED

• Hill EB, Reisdorph RM, Rasolofomanana-Rajery S, Michel C, Khajeh-Sharafabadi M, Doenges KA, Weaver N, Quinn K, Sutliff AK, Tang M, Borengasser SJ, Frank DN, O'Connor LE, Campbell WW, Krebs NF, Hendricks AE, Reisdorph NA. Salmon Food-Specific Compounds and Their Metabolites Increase in Human Plasma and Are Associated with Cardiometabolic Health Indicators Following a Mediterranean-Style Diet Intervention. J Nutr. 2024 Jan;154(1):26-40. doi: 10.1016/j.tjnut.2023.10.024. Epub 2023 Oct 31.

  PMID: 37918675 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Nancy F Krebs, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

• Nichole Reisdorph, PhD

  University of Colorado School of Pharmacy

  PRINCIPAL INVESTIGATOR

• Wayne Campbell, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete a 16-week randomized cross-over semi-controlled feeding study comparing two isocaloric dietary interventions. The two diets will be a 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) and their habitual/Western (Western) diet, Participants will be randomized (1:1) to start one of the dietary interventions, with subsequent assignment to the other upon completion of the first. A permuted block randomization scheme using block size of 2 and stratification by sex will be utilized to ensure balance between intervention order and number of males and females in each arm.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 15, 2022
• Study Start: November 21, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available within 12 months of publication of results for a minimum period of 3 years.

Locations

US (1)