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

NCT04635917 | Completed DMC

• 2 other identifiers: 2022561R00MD012815
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Intervention

Keywords

Personalized

Outcome Measures

Primary Outcomes (10)

• Change in diet quality

  Healthy eating index score

  Change over 8 weeks

• Change in relative intensities of metabolites in blood

  Measured by untargeted metabolomics mass spectrometry

  Change over 8 weeks

• Change in stool microbiome profiles

  16s rRNA sequencing

  Change over 8 weeks

• Change in endothelial function

  Reactive hyperemia index

  Change over 8 weeks

• Matsuda index

  Assessed via a 2-hour oral glucose tolerance test

  Change over 8 weeks

• Change in lipid profile

  LDL, HDL, triglycerides, total cholesterol

  Change over 8 weeks

• Change in glucoregulation

  Fasting glucose concentrations

  Change over 8 weeks

• Change in insulinemic biomarker concentrations

  Fasting insulin and C-peptide concentrations

  Change over 8 weeks

• Change in blood pressure

  Diastolic and systolic blood pressure

  Change over 8 weeks

• Change in inflammatory markers

  MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen

  Change over 8 weeks

Secondary Outcomes (7)

• Body Mass

  Every 2 weeks over the 8 week intervention

• Body Composition

  Every 2 weeks over the 8 week intervention

• Anthropometrics

  Every 2 weeks over the 8 week intervention

• 24-hour appetite ratings

  Every 4 weeks over the 8 week intervention

• Physical activity

  Every 4 weeks over the 8 week intervention

Other Outcomes (4)

• Transcriptomics profiles

  Baseline and at the end of the 8-week intervention

• Attention score

  Change over 8 weeks

• Memory

  Change over 8 weeks

Study Arms (4)

Personalized diet - Black adults

EXPERIMENTAL

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.

Other: Personalized diet

Personalized diet - White adults

EXPERIMENTAL

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.

Other: Personalized diet

Conventional dietary advice- Black adults

OTHER

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

Other: Conventional dietary advice

Conventional dietary advice- White adults

OTHER

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

Other: Conventional dietary advice

Interventions

Personalized diet 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.

Also known as: PD

Personalized diet - Black adults; Personalized diet - White adults

Conventional dietary advice OTHER

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

Also known as: CD

Conventional dietary advice- Black adults; Conventional dietary advice- White adults

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

Study Officials

• Jaapna Dhillon, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Nutrition & Exercise Phys-MED

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 19, 2020
• Study Start: December 22, 2020
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be deposited in NIH supported data repositories.

Locations

US (1)