Diet Intervention Clinical Trial
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri-Columbia | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Transcriptomics profiles | Untargeted transcriptomics | Baseline and at the end of the 8-week intervention | |
Other | Attention score | d2 test of attention | Change over 8 weeks | |
Other | Memory | Word recall scores | Change over 8 weeks | |
Other | Food environment perceptions | Subjective and objective questionnaires | Baseline and at the end of the 8-week intervention | |
Primary | Change in diet quality | Healthy eating index score | Change over 8 weeks | |
Primary | Change in relative intensities of metabolites in blood | Measured by untargeted metabolomics mass spectrometry | Change over 8 weeks | |
Primary | Change in stool microbiome profiles | 16s rRNA sequencing | Change over 8 weeks | |
Primary | Change in endothelial function | Reactive hyperemia index | Change over 8 weeks | |
Primary | Matsuda index | Assessed via a 2-hour oral glucose tolerance test | Change over 8 weeks | |
Primary | Change in lipid profile | LDL, HDL, triglycerides, total cholesterol | Change over 8 weeks | |
Primary | Change in glucoregulation | Fasting glucose concentrations | Change over 8 weeks | |
Primary | Change in insulinemic biomarker concentrations | Fasting insulin and C-peptide concentrations | Change over 8 weeks | |
Primary | Change in blood pressure | Diastolic and systolic blood pressure | Change over 8 weeks | |
Primary | Change in inflammatory markers | MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen | Change over 8 weeks | |
Secondary | Body Mass | Body mass will be measured in kg | Every 2 weeks over the 8 week intervention | |
Secondary | Body Composition | Fat mass, fat-free mass | Every 2 weeks over the 8 week intervention | |
Secondary | Anthropometrics | Waist circumference, hip circumference | Every 2 weeks over the 8 week intervention | |
Secondary | 24-hour appetite ratings | Subjective ratings using visual analog scales | Every 4 weeks over the 8 week intervention | |
Secondary | Physical activity | Activity assessment using Actigraphs | Every 4 weeks over the 8 week intervention | |
Secondary | Palatability rating of foods | Hedonic general labelled magnitude scale (gLMS) | Every 2 weeks over the 8 week intervention | |
Secondary | Acceptance rating of foods | 9-point food action rating scale | Every 2 weeks over the 8 week intervention |
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