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

Diet Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635917
• Other study ID #: 2022561
• Secondary ID: R00MD012815
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Jaapna Dhillon, PhD
• Phone: 573-884-2103
• Email: jdhillon[@]missouir.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diet Intervention

Intervention

Other:
• Personalized diet
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.
• Conventional dietary advice
Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

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