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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04635917
Other study ID # 2022561
Secondary ID R00MD012815
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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