Personalized Diet for Cardiometabolic Health

Overseen By Rebecca Welly, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Antibiotics, Metabolism drugs

Disqualifiers: Drug use, Heart disease, Hypertension, Diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

112 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 7 8 10}

Research Team

Jaapna Dhillon, PhD

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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.

Exclusion Criteria

You are currently pregnant or breastfeeding.

You have used illegal drugs.

I am not currently taking antibiotics.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Personalized diet - White adults Experimental Treatment 1 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 adults Experimental Treatment 1 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 adults Experimental Treatment 1 Intervention

Young White adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.

Group IV: Conventional dietary advice- Black adults Experimental Treatment 1 Intervention

Young Black adults will receive non-personalized, conventional dietary advice based on the MyPlate guidelines.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition recommendations and principles for people with diabetes mellitus. [2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. [2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. [2022]

In a study involving 155 participants aged 25 to 70, personalized nutrition advice (PNA) led to significant improvements in dietary intake, including increased consumption of fruits, whole grains, and fish, compared to those receiving generic nutrition advice (GNA) or no advice.

Setting personal dietary goals within the PNA group further enhanced positive changes in food choices, demonstrating that tailored advice and goal-setting can effectively promote healthier eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Food-Intake Behavior in a Healthy Population: Personalized vs. One-Size-Fits-All. Hoevenaars, FPM., Berendsen, CMM., Pasman, WJ., et al.[2021]

Personalized nutrition (PN) interventions lead to greater improvements in dietary intake compared to generalized dietary advice, based on a systematic review of 11 randomized controlled trials involving 57 to 1488 participants across the US, Canada, and Europe.

The studies showed a low risk of bias and varied follow-up durations from 1 to 12 months, indicating that tailored dietary advice can be more effective, but further research is needed to explore different personalization methods and incorporate behavior-change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Jinnette, R., Narita, A., Manning, B., et al.[2023]

A survey of 8233 participants across eight European countries revealed that about 30% are willing to pay more for personalized nutrition (PN) services compared to standard dietary advice, indicating a potential market for PN.

On average, those willing to pay for PN were prepared to spend about 150% of the cost of standard advice, with higher interest noted among men with higher incomes, suggesting socio-demographic factors influence willingness to invest in personalized nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Willingness to pay for personalised nutrition across Europe. Fischer, AR., Berezowska, A., van der Lans, IA., et al.[2018]

The Mediterranean diet is strongly supported by evidence showing significant reductions in mortality rates and heart attack occurrences, making it a highly recommended option for patients aiming to reduce cardiovascular disease risk.

While popular diets like Atkins and South Beach are effective for weight loss, they lack substantial evidence for long-term health benefits, highlighting the importance of focusing on patient-oriented outcomes in dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diets for cardiovascular disease prevention: what is the evidence? Walker, C., Reamy, BV.[2022]

A heart-healthy diet should focus on increasing plant-based foods and healthy unsaturated fats while reducing processed foods, sodium, refined sugars, and saturated fats, as supported by recent research.

Incorporating lifestyle changes like exercise and time-restricted eating can enhance the benefits of dietary modifications, and physicians should consider patients' cultural preferences and accessibility when recommending these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart-Healthy Diets and the Cardiometabolic Jackpot. Ormiston, CK., Rosander, A., Taub, PR.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Personalised Nutrition: Updates, Gaps and Next Steps. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Nutrition recommendations and principles for people with diabetes mellitus. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Food-Intake Behavior in a Healthy Population: Personalized vs. One-Size-Fits-All. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Willingness to pay for personalised nutrition across Europe. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Diets for cardiovascular disease prevention: what is the evidence? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Heart-Healthy Diets and the Cardiometabolic Jackpot. [2022]