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

July 9, 2025 updated by: Jaapna Dhillon, University of Missouri-Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in diet quality
Time Frame: Change over 8 weeks
Healthy eating index score
Change over 8 weeks
Change in relative intensities of metabolites in blood
Time Frame: Change over 8 weeks
Measured by untargeted metabolomics mass spectrometry
Change over 8 weeks
Change in stool microbiome profiles
Time Frame: Change over 8 weeks
16s rRNA sequencing
Change over 8 weeks
Change in endothelial function
Time Frame: Change over 8 weeks
Reactive hyperemia index
Change over 8 weeks
Matsuda index
Time Frame: Change over 8 weeks
Assessed via a 2-hour oral glucose tolerance test
Change over 8 weeks
Change in lipid profile
Time Frame: Change over 8 weeks
LDL, HDL, triglycerides, total cholesterol
Change over 8 weeks
Change in glucoregulation
Time Frame: Change over 8 weeks
Fasting glucose concentrations
Change over 8 weeks
Change in insulinemic biomarker concentrations
Time Frame: Change over 8 weeks
Fasting insulin and C-peptide concentrations
Change over 8 weeks
Change in blood pressure
Time Frame: Change over 8 weeks
Diastolic and systolic blood pressure
Change over 8 weeks
Change in inflammatory markers
Time Frame: Change over 8 weeks
MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen
Change over 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass
Time Frame: Every 2 weeks over the 8 week intervention
Body mass will be measured in kg
Every 2 weeks over the 8 week intervention
Body Composition
Time Frame: Every 2 weeks over the 8 week intervention
Fat mass, fat-free mass
Every 2 weeks over the 8 week intervention
Anthropometrics
Time Frame: Every 2 weeks over the 8 week intervention
Waist circumference, hip circumference
Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Time Frame: Every 4 weeks over the 8 week intervention
Subjective ratings using visual analog scales
Every 4 weeks over the 8 week intervention
Physical activity
Time Frame: Every 4 weeks over the 8 week intervention
Activity assessment using Actigraphs
Every 4 weeks over the 8 week intervention
Palatability rating of foods
Time Frame: Every 2 weeks over the 8 week intervention
Hedonic general labelled magnitude scale (gLMS)
Every 2 weeks over the 8 week intervention
Acceptance rating of foods
Time Frame: Every 2 weeks over the 8 week intervention
9-point food action rating scale
Every 2 weeks over the 8 week intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transcriptomics profiles
Time Frame: Baseline and at the end of the 8-week intervention
Untargeted transcriptomics
Baseline and at the end of the 8-week intervention
Attention score
Time Frame: Change over 8 weeks
d2 test of attention
Change over 8 weeks
Memory
Time Frame: Change over 8 weeks
Word recall scores
Change over 8 weeks
Food environment perceptions
Time Frame: Baseline and at the end of the 8-week intervention
Subjective and objective questionnaires
Baseline and at the end of the 8-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaapna Dhillon, PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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