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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks over the 8 week intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 18 and 35 years old.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in blood pressure
Change in diet quality
Change in endothelial function
+7 moreSecondary outcome measures
24-hour appetite ratings
Acceptance rating of foods
Anthropometrics
+4 moreOther outcome measures
Attention score
Food environment perceptions
Memory
+1 moreTrial 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
362 Previous Clinical Trials
627,994 Total Patients Enrolled
1 Trials studying Diet Intervention
60 Patients Enrolled for Diet Intervention
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,091 Total Patients Enrolled
Jaapna Dhillon, PhDPrincipal Investigator - University of Missouri-Columbia
University of Missouri-Columbia
2 Previous Clinical Trials
94 Total Patients Enrolled
1 Trials studying Diet Intervention
60 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being included in this trial?
"The minimum age requirement for this clinical trial is 18 and the upper limit of eligibility is 35."
Answered by AI
How many participants has this research endeavor recruited so far?
"Affirmative. According to clinicaltrials.gov, this medical experiment is still enrolling participants who meet the criteria. First posted on December 22nd 2020 and last updated October 1st 2021, 120 individuals are being accepted at a single site."
Answered by AI
Is this medical study recruiting participants currently?
"The clinical trial is actively looking for participants, as reported on the website. The first post was made December 22nd 2020 and there have been subsequent edits up to October 1st 2021."
Answered by AI
What is the underlying mission of this trial?
"This research is set to run over 8 weeks in order to assess changes in blood pressure. Other objectives include gauging the palatability of food with a Hedonic general labelled magnitude scale (gLMS), 24-hour appetite ratings using visual analog scales, and physical activity levels monitored by Actigraphs."
Answered by AI
What qualifications must an individual meet to become a participant in this research?
"This particular medical study necessitates the recruitment of 120 participants aged 18 to 35 that are willing to follow a nutritionally-focused regimen. In order to qualify, individuals must be non-smokers for more than 12 months and have maintained stable weight (no greater than 5 kg change over last 3 months), as well as demonstrate Black or Hispanic ethnicity or Non-Hispanic White identity, with BMI between 25 and 45 kg/m2."
Answered by AI
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