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| ID | Type | Description | Link |
|---|---|---|---|
| R00MD012815 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Conventional dietary advice- Black adults | Other | Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. |
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| Conventional dietary advice- White adults | Other | Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diet quality | Healthy eating index score | Change over 8 weeks |
| Change in relative intensities of metabolites in blood | Measured by untargeted metabolomics mass spectrometry | Change over 8 weeks |
| Change in stool microbiome profiles | 16s rRNA sequencing | Change over 8 weeks |
| Change in endothelial function | Reactive hyperemia index | Change over 8 weeks |
| Matsuda index | Assessed via a 2-hour oral glucose tolerance test | Change over 8 weeks |
| Change in lipid profile | LDL, HDL, triglycerides, total cholesterol | Change over 8 weeks |
| Change in glucoregulation | Fasting glucose concentrations | Change over 8 weeks |
| Change in insulinemic biomarker concentrations | Fasting insulin and C-peptide concentrations | Change over 8 weeks |
| Change in blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass | Body mass will be measured in kg | Every 2 weeks over the 8 week intervention |
| Body Composition | Fat mass, fat-free mass | Every 2 weeks over the 8 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Transcriptomics profiles | Untargeted transcriptomics | Baseline and at the end of the 8-week intervention |
| Attention score | d2 test of attention |
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaapna Dhillon, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65211 | United States |
Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Immediately following publication. No end date.
Data will be deposited in NIH supported data repositories.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 22, 2025 | |
| Reset | Jan 13, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 8, 2024 | Jul 9, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 22, 2025 | Jan 13, 2026 |
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| Conventional dietary advice | Other | Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines. |
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Diastolic and systolic blood pressure |
| Change over 8 weeks |
| Change in inflammatory markers | MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen | Change over 8 weeks |
| Anthropometrics | Waist circumference, hip circumference | Every 2 weeks over the 8 week intervention |
| 24-hour appetite ratings | Subjective ratings using visual analog scales | Every 4 weeks over the 8 week intervention |
| Physical activity | Activity assessment using Actigraphs | Every 4 weeks over the 8 week intervention |
| Palatability rating of foods | Hedonic general labelled magnitude scale (gLMS) | Every 2 weeks over the 8 week intervention |
| Acceptance rating of foods | 9-point food action rating scale | Every 2 weeks over the 8 week intervention |
| Change over 8 weeks |
| Memory | Word recall scores | Change over 8 weeks |
| Food environment perceptions | Subjective and objective questionnaires | Baseline and at the end of the 8-week intervention |