112 Participants Needed

Personalized Diet for Cardiometabolic Health

JD
RW
Overseen ByRebecca Welly, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it excludes those who have recently started medications affecting metabolism or appetite, and those requiring drug therapy for certain heart conditions or dyslipidemia (abnormal cholesterol levels). It's best to discuss your specific medications with the trial coordinators.

Is personalized nutrition generally safe for humans?

The available research on personalized nutrition, which tailors dietary advice to individual needs, does not report any safety concerns in healthy adults. These studies focus on improving dietary intake and behavior without indicating any adverse effects.12345

How is the personalized diet treatment different from other treatments for cardiometabolic health?

The personalized diet treatment is unique because it tailors dietary advice to an individual's specific characteristics, such as lifestyle, blood, and DNA profiles, rather than providing general dietary guidelines. This approach aims to improve dietary intake and health outcomes more effectively by considering personal health data and preferences.23567

What data supports the effectiveness of the treatment Personalized Diet for Cardiometabolic Health?

Research suggests that personalized nutrition, which tailors eating advice to individual needs, can effectively improve health by considering unique genetic and lifestyle factors. This approach has shown promise in managing conditions like diabetes by customizing dietary recommendations to meet specific health goals.568910

Who Is on the Research Team?

JD

Jaapna Dhillon, PhD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Consistent diet and activity patterns for 4 weeks
Willing to comply with study protocol
Both Black people, including those of Hispanic background, and White people, including those who are not of Hispanic background, are eligible.
See 4 more

Exclusion Criteria

You are currently pregnant or breastfeeding.
You have used illegal drugs.
I am not currently taking antibiotics.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized dietary intervention or conventional dietary advice over 8 weeks

8 weeks
Visits every 2 weeks for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional dietary advice
  • Personalized diet
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Personalized diet - White adultsExperimental Treatment1 Intervention
Group II: Personalized diet - Black adultsExperimental Treatment1 Intervention
Group III: Conventional dietary advice- White adultsExperimental Treatment1 Intervention
Group IV: Conventional dietary advice- Black adultsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Published Research Related to This Trial

Personalized nutrition approaches offer tailored dietary advice that meets the specific nutritional needs of individuals, potentially leading to better health outcomes.
These approaches can help individuals make healthier food choices by considering their unique dietary requirements, preferences, and health goals.
Personalised Nutrition: Updates, Gaps and Next Steps.Biesiekierski, JR., Livingstone, KM., Moschonis, G.[2020]
Personalized nutrition (PN) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.
The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.
Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association.Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]
There is no single 'diabetic' diet; instead, nutrition recommendations for people with diabetes should be personalized based on individual assessment, treatment goals, and lifestyle factors.
Ongoing education and monitoring of metabolic parameters, such as blood glucose and body weight, are essential for effective diabetes management and achieving desired health outcomes.
Nutrition recommendations and principles for people with diabetes mellitus.[2015]

Citations

Personalised Nutrition: Updates, Gaps and Next Steps. [2020]
Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]
Nutrition recommendations and principles for people with diabetes mellitus. [2015]
Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. [2015]
Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. [2022]
Evaluation of Food-Intake Behavior in a Healthy Population: Personalized vs. One-Size-Fits-All. [2021]
Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]
Willingness to pay for personalised nutrition across Europe. [2018]
Diets for cardiovascular disease prevention: what is the evidence? [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Heart-Healthy Diets and the Cardiometabolic Jackpot. [2022]
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