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

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

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.

Study Overview

• Status: Completed
• Conditions: Diet Intervention
• Intervention / Treatment: Other: Personalized diet; Other: Conventional dietary advice

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: PD
Experimental: 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.	Other: 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.; Other Names: PD
Other: Conventional dietary advice- Black adults; Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.	Other: Conventional dietary advice; Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.; Other Names: CD
Other: Conventional dietary advice- White adults; Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.	Other: Conventional dietary advice; Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.; Other Names: CD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass	Body mass will be measured in kg	Every 2 weeks over the 8 week intervention
Body Composition	Fat mass, fat-free mass	Every 2 weeks over the 8 week intervention
Anthropometrics	Waist circumference, hip circumference	Every 2 weeks over the 8 week intervention
24-hour appetite ratings	Subjective ratings using visual analog scales	Every 4 weeks over the 8 week intervention
Physical activity	Activity assessment using Actigraphs	Every 4 weeks over the 8 week intervention
Palatability rating of foods	Hedonic general labelled magnitude scale (gLMS)	Every 2 weeks over the 8 week intervention
Acceptance rating of foods	9-point food action rating scale	Every 2 weeks over the 8 week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcriptomics profiles	Untargeted transcriptomics	Baseline and at the end of the 8-week intervention
Attention score	d2 test of attention	Change over 8 weeks
Memory	Word recall scores	Change over 8 weeks
Food environment perceptions	Subjective and objective questionnaires	Baseline and at the end of the 8-week intervention

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Jaapna Dhillon, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): December 21, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Personalized
• Other Study ID Numbers: 2022561; R00MD012815 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Data will be deposited in NIH supported data repositories.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No