An interventional study of Personalized diet and Conventional dietary advice in Diet Intervention, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.
Other: Conventional dietary advice
Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.
Other: Conventional dietary advice
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.
Also known as: PD
Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.
Also known as: CD
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
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
Transcriptomics profiles
Untargeted transcriptomics
Time frame: Baseline and at the end of the 8-week intervention
Attention score
d2 test of attention
Time frame: Change over 8 weeks
Memory
Word recall scores
Time frame: Change over 8 weeks
Food environment perceptions
Subjective and objective questionnaires
Time frame: Baseline and at the end of the 8-week intervention
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Supporting information: Study protocol
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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University of Missouri-Columbia