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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
112
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.
Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.
University of Missouri-Columbia
Columbia, Missouri, United States
Change in diet quality
Healthy eating index score
Time frame: Change over 8 weeks
Change in relative intensities of metabolites in blood
Measured by untargeted metabolomics mass spectrometry
Time frame: Change over 8 weeks
Change in stool microbiome profiles
16s rRNA sequencing
Time frame: Change over 8 weeks
Change in endothelial function
Reactive hyperemia index
Time frame: Change over 8 weeks
Matsuda index
Assessed via a 2-hour oral glucose tolerance test
Time frame: Change over 8 weeks
Change in lipid profile
LDL, HDL, triglycerides, total cholesterol
Time frame: Change over 8 weeks
Change in glucoregulation
Fasting glucose concentrations
Time frame: Change over 8 weeks
Change in insulinemic biomarker concentrations
Fasting insulin and C-peptide concentrations
Time frame: Change over 8 weeks
Change in blood pressure
Diastolic and systolic blood pressure
Time frame: Change over 8 weeks
Change in inflammatory markers
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MCP-1,IL6, IL10, TNFa, hs-CRP, and fibrinogen
Time frame: Change over 8 weeks
Body Mass
Body mass will be measured in kg
Time frame: Every 2 weeks over the 8 week intervention
Body Composition
Fat mass, fat-free mass
Time frame: Every 2 weeks over the 8 week intervention
Anthropometrics
Waist circumference, hip circumference
Time frame: Every 2 weeks over the 8 week intervention
24-hour appetite ratings
Subjective ratings using visual analog scales
Time frame: Every 4 weeks over the 8 week intervention
Physical activity
Activity assessment using Actigraphs
Time frame: Every 4 weeks over the 8 week intervention
Palatability rating of foods
Hedonic general labelled magnitude scale (gLMS)
Time frame: Every 2 weeks over the 8 week intervention
Acceptance rating of foods
9-point food action rating scale
Time frame: Every 2 weeks over the 8 week intervention