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

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

Non Recruiting
18-35 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Diet Intervention

NCT04635917

University of Missouri-Columbia

20 August 2025

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