Diet InterventionNCT04635917
Effects of a Personalized Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults
A study testing Personalized diet and Conventional dietary advice in people with Diet Intervention, run by University of Missouri-Columbia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Intervention
- What is being tested?
- Personalized diet and Conventional dietary advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 21 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Gastrointestinal disease and/or bariatric surgery
- HIV positivity
- Pregnant or lactating individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Intervention
- Being tested
- Personalized diet, Conventional dietary advice
- Keywords
- Personalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized dietOther
Also called PD
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.
Conventional dietary adviceOther
Also called CD
Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Personalized diet - Black adults | Experimental | 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. Receives: Other: Personalized diet |
| Personalized diet - White adults | Experimental | 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. Receives: Other: Personalized diet |
| Conventional dietary advice- Black adults | Other | Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. Receives: Other: Conventional dietary advice |
| Conventional dietary advice- White adults | Other | Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. Receives: Other: Conventional dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet quality
Healthy eating index score
Measured: Change over 8 weeks
Change in relative intensities of metabolites in blood
Measured by untargeted metabolomics mass spectrometry
Measured: Change over 8 weeks
Change in stool microbiome profiles
16s rRNA sequencing
Measured: Change over 8 weeks
Change in endothelial function
Reactive hyperemia index
Measured: Change over 8 weeks
Matsuda index
Assessed via a 2-hour oral glucose tolerance test
Measured: Change over 8 weeks
Change in lipid profile
LDL, HDL, triglycerides, total cholesterol
Measured: Change over 8 weeks
Change in glucoregulation
Fasting glucose concentrations
Measured: Change over 8 weeks
Change in insulinemic biomarker concentrations
Fasting insulin and C-peptide concentrations
Measured: Change over 8 weeks
Change in blood pressure
Diastolic and systolic blood pressure
Measured: Change over 8 weeks
Change in inflammatory markers
MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen
Measured: Change over 8 weeks
Secondary outcomes (7)
Body Mass
Body mass will be measured in kg
Measured: Every 2 weeks over the 8 week intervention
Body Composition
Fat mass, fat-free mass
Measured: Every 2 weeks over the 8 week intervention
Anthropometrics
Waist circumference, hip circumference
Measured: Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Subjective ratings using visual analog scales
Measured: Every 4 weeks over the 8 week intervention
Physical activity
Activity assessment using Actigraphs
Measured: Every 4 weeks over the 8 week intervention
Palatability rating of foods
Hedonic general labelled magnitude scale (gLMS)
Measured: Every 2 weeks over the 8 week intervention
Acceptance rating of foods
9-point food action rating scale
Measured: Every 2 weeks over the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start22 Dec 2020
- Primary completion21 Dec 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet InterventionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jaapna Dhillon, University of Missouri-Columbia
- Investigators
- Jaapna Dhillon, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635917
- Sponsor's protocol ID
- 2022561
- Other IDs
- R00MD012815
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2020
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Personalized Functional Food Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults
- ClinicalTrials.gov ID
- NCT04635917
- Acronym / sponsor ID
- 2022561
- Conditions
- Diet Intervention
- Keywords
- Personalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Personalized diet - Black adults | Experimental | Other: Personalized dietYoung 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. |
| Personalized diet - White adults | Experimental | Other: Personalized dietYoung 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. |
| Conventional dietary advice- Black adults | Other | Other: Conventional dietary adviceYoung Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. |
| Conventional dietary advice- White adults | Other | Other: Conventional dietary adviceYoung White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized dietAlso: PDParticipants 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 | Personalized diet - Black adults, Personalized diet - White adults |
| Conventional dietary adviceAlso: CDParticipants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines. | Other | Conventional dietary advice- Black adults, Conventional dietary advice- White adults |
Primary outcome
Change in diet quality
Time frame: Change over 8 weeks
Healthy eating index score
Change in relative intensities of metabolites in blood
Time frame: Change over 8 weeks
Measured by untargeted metabolomics mass spectrometry
Change in stool microbiome profiles
Time frame: Change over 8 weeks
16s rRNA sequencing
Change in endothelial function
Time frame: Change over 8 weeks
Reactive hyperemia index
Matsuda index
Time frame: Change over 8 weeks
Assessed via a 2-hour oral glucose tolerance test
Change in lipid profile
Time frame: Change over 8 weeks
LDL, HDL, triglycerides, total cholesterol
Change in glucoregulation
Time frame: Change over 8 weeks
Fasting glucose concentrations
Change in insulinemic biomarker concentrations
Time frame: Change over 8 weeks
Fasting insulin and C-peptide concentrations
Change in blood pressure
Time frame: Change over 8 weeks
Diastolic and systolic blood pressure
Change in inflammatory markers
Time frame: Change over 8 weeks
MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen
7 secondary outcomes
Body Mass
Time frame: Every 2 weeks over the 8 week intervention
Body Composition
Time frame: Every 2 weeks over the 8 week intervention
Anthropometrics
Time frame: Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Time frame: Every 4 weeks over the 8 week intervention
Physical activity
Time frame: Every 4 weeks over the 8 week intervention
Palatability rating of foods
Time frame: Every 2 weeks over the 8 week intervention
Acceptance rating of foods
Time frame: Every 2 weeks over the 8 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaapna Dhillon, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized diet and Conventional dietary advice in people with Diet Intervention, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diet quality (time frame: Change over 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.