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Personalized Diet for Cardiometabolic Health
N/A
Recruiting
Led By Jaapna Dhillon, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-smoker >1 year or more
Age: 18-35 years of age
Must not have
Coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia requiring drug therapy
Uncontrolled hypertension and blood pressure ≥ 180/110 Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks over the 8 week intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how a better diet impacts heart health and metabolism for black and white adults, as well as how the gut microbiome is affected.
Who is the study for?
This trial is for young Black and non-Hispanic White adults aged 18-35 with a BMI of 25-45. Participants should have stable weight, consistent diet and activity patterns, be non-smokers for at least a year, and willing to eat nuts, fruits, and vegetables. Those with allergies to these foods, gastrointestinal issues or surgery history, HIV positive status or recent drug use affecting metabolism are excluded.
What is being tested?
The study compares the effects of personalized dietary advice versus conventional dietary guidance on heart health outcomes and how they relate to gut bacteria in minority young adults. It aims to see if tailored diets can better improve body's sugar and fat processing compared to standard advice.
What are the potential side effects?
Since this trial involves dietary changes rather than medication or invasive procedures, side effects may include digestive discomfort as the body adjusts to new foods. However specific side effects will depend on individual reactions to the diet changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not smoked for over a year.
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I am between 18 and 35 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on medication for heart disease or high cholesterol.
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My blood pressure is very high and I have diabetes.
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I am HIV positive.
Select...
I have a gastrointestinal condition or have had bariatric surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 4 weeks over the 8 week intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks over the 8 week intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in blood pressure
Change in diet quality
Change in endothelial function
+7 moreSecondary study objectives
24-hour appetite ratings
Acceptance rating of foods
Anthropometrics
+4 moreOther study objectives
Attention score
Food environment perceptions
Memory
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Personalized diet - White adultsExperimental Treatment1 Intervention
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.
Group II: Personalized diet - Black adultsExperimental Treatment1 Intervention
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.
Group III: Conventional dietary advice- White adultsExperimental Treatment1 Intervention
Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.
Group IV: Conventional dietary advice- Black adultsExperimental Treatment1 Intervention
Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,374 Total Patients Enrolled
2 Trials studying Diet Intervention
150 Patients Enrolled for Diet Intervention
National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,378,713 Total Patients Enrolled
Jaapna Dhillon, PhDPrincipal Investigator - University of Missouri-Columbia
University of Missouri-Columbia
3 Previous Clinical Trials
184 Total Patients Enrolled
2 Trials studying Diet Intervention
150 Patients Enrolled for Diet Intervention
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently pregnant or breastfeeding.You have used illegal drugs.I am not currently taking antibiotics.I recently started taking medication that changes my metabolism or appetite.Both Black people, including those of Hispanic background, and White people, including those who are not of Hispanic background, are eligible.I have not smoked for over a year.I am on medication for heart disease or high cholesterol.My blood pressure is very high and I have diabetes.I am HIV positive.I am between 18 and 35 years old.Your body mass index (BMI) falls between 25 and 45.I have a gastrointestinal condition or have had bariatric surgery.You are allergic to any of the fruits, vegetables, or nuts provided in the study.You are willing to eat nuts, fruits, and vegetables.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized diet - White adults
- Group 2: Personalized diet - Black adults
- Group 3: Conventional dietary advice- White adults
- Group 4: Conventional dietary advice- Black adults
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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