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

Not Applicable

Completed

• Conditions: Diet Intervention

• Registration Number: NCT04635917
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Study Start: 2020-12-22
• Primary Completion: 2024-12-21
• Study Completion: 2024-12-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in diet quality	Change over 8 weeks	Healthy eating index score
Change in glucoregulation	Change over 8 weeks	Fasting glucose concentrations
Change in relative intensities of metabolites in blood	Change over 8 weeks	Measured by untargeted metabolomics mass spectrometry
Change in endothelial function	Change over 8 weeks	Reactive hyperemia index
Change in lipid profile	Change over 8 weeks	LDL, HDL, triglycerides, total cholesterol
Change in insulinemic biomarker concentrations	Change over 8 weeks	Fasting insulin and C-peptide concentrations
Change in blood pressure	Change over 8 weeks	Diastolic and systolic blood pressure
Change in stool microbiome profiles	Change over 8 weeks	16s rRNA sequencing
Matsuda index	Change over 8 weeks	Assessed via a 2-hour oral glucose tolerance test
Change in inflammatory markers	Change over 8 weeks	MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States