Clinical trial NCT04635917: Effects of a Personalized Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults
Official title: Effects of a Personalized Functional Food Diet on Cardiometabolic, Microbiome and Metabolomics Profiles in Minority Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Intervention
Keywords: Personalized
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-11-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in diet quality
timeFrame: Change over 8 weeks
measure: Change in relative intensities of metabolites in blood
timeFrame: Change over 8 weeks
measure: Change in stool microbiome profiles
timeFrame: Change over 8 weeks
measure: Change in endothelial function
timeFrame: Change over 8 weeks
measure: Matsuda index
timeFrame: Change over 8 weeks
measure: Change in lipid profile
timeFrame: Change over 8 weeks
measure: Change in glucoregulation
timeFrame: Change over 8 weeks
measure: Change in insulinemic biomarker concentrations
timeFrame: Change over 8 weeks
measure: Change in blood pressure
timeFrame: Change over 8 weeks
measure: Change in inflammatory markers
timeFrame: Change over 8 weeks
Secondary outcomes:
measure: Body Mass
timeFrame: Every 2 weeks over the 8 week intervention
measure: Body Composition
timeFrame: Every 2 weeks over the 8 week intervention
measure: Anthropometrics
timeFrame: Every 2 weeks over the 8 week intervention
measure: 24-hour appetite ratings
timeFrame: Every 4 weeks over the 8 week intervention
measure: Physical activity
timeFrame: Every 4 weeks over the 8 week intervention
measure: Palatability rating of foods
timeFrame: Every 2 weeks over the 8 week intervention
measure: Acceptance rating of foods
timeFrame: Every 2 weeks over the 8 week intervention
Other outcomes:
measure: Transcriptomics profiles
timeFrame: Baseline and at the end of the 8-week intervention
measure: Attention score
timeFrame: Change over 8 weeks
measure: Memory
timeFrame: Change over 8 weeks
measure: Food environment perceptions
timeFrame: Baseline and at the end of the 8-week intervention
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jaapna Dhillon, PhD
role: PRINCIPAL_INVESTIGATOR
References: