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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diet Intervention

Intervention / Treatment
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* Other: Personalized diet
* Other: Conventional dietary advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized diet - Black adults<br>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<br>* 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.<br>* Other names: PD;|
| Experimental: Personalized diet - White adults<br>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<br>* 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.<br>* Other names: PD;|
| Other: Conventional dietary advice- Black adults<br>Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. | Other: Conventional dietary advice<br>* Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.<br>* Other names: CD;|
| Other: Conventional dietary advice- White adults<br>Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines. | Other: Conventional dietary advice<br>* Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.<br>* Other names: CD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized