Effects of a Personalized Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults

University of Missouri (MU)

Status: Completed

Conditions: Diet Intervention

Treatments: Other: Personalized diet; Other: Conventional dietary advice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04635917

2022561

R00MD012815 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The proposed study has two primary objectives i.e. to examine how improvements in diet quality via a personalized dietary intervention 1) benefit cardiometabolic outcomes in young Black adults differentially compared to non-Hispanic White adults, and 2) improve carbohydrate and lipid metabolism in relation to the gut microbiome.

Full description

The study is an 8-wk randomized, controlled, parallel arm clinical trial in which participants (age: 18-35 years, BMI: 25-45 kg/m2, race/ethnicity: Black or White) will be block randomized to a personalized dietary intervention or to receive conventional dietary advice. Outcomes assessed will include metabolites involved in carbohydrate and lipid regulation, gut microbiome composition, and cardiometabolic biomarkers.

Enrollment: 112 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 18-35 years of age
• BMI: 25-45 kg/m2
• Black including those of Hispanic ethnicity, and Non-Hispanic White individuals
• Willingness to consume nuts, fruits and vegetables
• Willing to comply with study protocol
• Consistent diet and activity patterns for 4 weeks
• Weight stable (≤5 kg change over the last 3 months) (Self-reported)
• Non-smoker >1 year or more

Exclusion criteria

• Allergies to fruits, vegetables, and nuts provided in the study
• Illicit drug use
• Recent start of medications that affect metabolism or appetite
• Antibiotics
• Coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia requiring drug therapy
• Uncontrolled hypertension and blood pressure ≥ 180/110 Diabetes
• Gastrointestinal disease and/or bariatric surgery
• HIV positivity
• Pregnant or lactating individuals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 4 patient groups

Personalized diet - Black adults

Experimental group

Description:

Young Black adults in this group will receive tailored nutrition counseling from a dietitian. To facilitate meeting their dietary goals, participants will be provided with nuts, fruits, and vegetables.

Treatment:

Other: Personalized diet

Personalized diet - White adults

Experimental group

Description:

Young White adults in this group will receive tailored nutrition counseling from a dietitian. To facilitate meeting their dietary goals, participants will be provided with nuts, fruits, and vegetables.

Treatment:

Other: Personalized diet

Conventional dietary advice- Black adults

Other group

Description:

Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.

Treatment:

Other: Conventional dietary advice

Conventional dietary advice- White adults

Other group

Description:

Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.

Treatment:

Other: Conventional dietary advice