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

NCT ID: NCT04635917

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2024-12-21

Brief Summary

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.

Detailed 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.

Conditions

Diet Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Personalized diet - Black adults

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.

Group Type: EXPERIMENTAL

Personalized diet

Intervention Type: OTHER

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

Personalized diet - White adults

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.

Group Type: EXPERIMENTAL

Personalized diet

Intervention Type: OTHER

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

Conventional dietary advice- Black adults

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

Group Type: OTHER

Conventional dietary advice

Intervention Type: OTHER

Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.

Conventional dietary advice- White adults

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

Group Type: OTHER

Conventional dietary advice

Intervention Type: OTHER

Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.

Interventions

Personalized diet

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

Intervention Type: OTHER

Conventional dietary advice

Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.

Intervention Type: OTHER

Other Intervention Names

PD; CD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jaapna Dhillon

Assistant Professor, Nutrition & Exercise Phys-MED

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaapna Dhillon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R00MD012815

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022561

Identifier Type: -

Identifier Source: org_study_id