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OpenTrials
Completed

NCT Number: NCT04635917

Effects of a Personalized 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.

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Key information

Conditions

Diet Intervention

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PD

Conventional dietary advice

Other

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

Other names: CD

Primary outcomes

  1. Change in diet quality

    Time frame: Change over 8 weeks

    Healthy eating index score

  2. Change in relative intensities of metabolites in blood

    Time frame: Change over 8 weeks

    Measured by untargeted metabolomics mass spectrometry

  3. Change in stool microbiome profiles

    Time frame: Change over 8 weeks

    16s rRNA sequencing

  4. Change in endothelial function

    Time frame: Change over 8 weeks

    Reactive hyperemia index

  5. Matsuda index

    Time frame: Change over 8 weeks

    Assessed via a 2-hour oral glucose tolerance test

  6. Change in lipid profile

    Time frame: Change over 8 weeks

    LDL, HDL, triglycerides, total cholesterol

  7. Change in glucoregulation

    Time frame: Change over 8 weeks

    Fasting glucose concentrations

  8. Change in insulinemic biomarker concentrations

    Time frame: Change over 8 weeks

    Fasting insulin and C-peptide concentrations

  9. Change in blood pressure

    Time frame: Change over 8 weeks

    Diastolic and systolic blood pressure

  10. Change in inflammatory markers

    Time frame: Change over 8 weeks

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

Secondary outcomes

  1. Body Mass

    Time frame: Every 2 weeks over the 8 week intervention

    Body mass will be measured in kg

  2. Body Composition

    Time frame: Every 2 weeks over the 8 week intervention

    Fat mass, fat-free mass

  3. Anthropometrics

    Time frame: Every 2 weeks over the 8 week intervention

    Waist circumference, hip circumference

  4. 24-hour appetite ratings

    Time frame: Every 4 weeks over the 8 week intervention

    Subjective ratings using visual analog scales

  5. Physical activity

    Time frame: Every 4 weeks over the 8 week intervention

    Activity assessment using Actigraphs

  6. Palatability rating of foods

    Time frame: Every 2 weeks over the 8 week intervention

    Hedonic general labelled magnitude scale (gLMS)

  7. Acceptance rating of foods

    Time frame: Every 2 weeks over the 8 week intervention

    9-point food action rating scale

Other outcomes

  1. Transcriptomics profiles

    Time frame: Baseline and at the end of the 8-week intervention

    Untargeted transcriptomics

  2. Attention score

    Time frame: Change over 8 weeks

    d2 test of attention

  3. Memory

    Time frame: Change over 8 weeks

    Word recall scores

  4. Food environment perceptions

    Time frame: Baseline and at the end of the 8-week intervention

    Subjective and objective questionnaires

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2020
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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