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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personalized diets can enhance heart and metabolic health, focusing on young Black and non-Hispanic White adults. Participants will receive either tailored nutrition advice with specific foods or general dietary guidance (conventional dietary advice). The researchers aim to determine if personalized diets more effectively improve heart health and metabolism compared to conventional advice, and how this relates to gut health. It is ideal for young adults who maintain a steady weight, are open to eating nuts, fruits, and vegetables, and do not smoke. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on personalized nutrition and its impact on health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that personalized diets are generally safe and easy to follow. Research indicates that these diets can significantly improve health measures such as blood fat levels, body weight, and waist size. These improvements are associated with better heart health and reduced cholesterol and blood pressure. No major safety issues have been reported with personalized diets, making them a safe option for those seeking to enhance their diet and health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized diet approach for improving cardiometabolic health because it tailors nutrition advice to each individual's unique needs, unlike the standard one-size-fits-all dietary guidelines, such as the MyPlate. This personalized method involves customized nutrition counseling from a dietitian and provides participants with specific foods like nuts, fruits, and vegetables to help them achieve their dietary goals. By focusing on individual differences, this approach has the potential to be more effective in managing and improving cardiometabolic health compared to conventional dietary advice.

What evidence suggests that this trial's treatments could be effective for cardiometabolic health?

Research has shown that personalized diets, one of the approaches tested in this trial, can be more effective than general dietary advice for improving heart and metabolic health. Studies have found that these customized diets help lower triglycerides (a type of fat in the blood) and improve body weight, waist size, and blood sugar levels. They also enhance diet quality and positively affect the gut microbiome, the collection of tiny organisms living in the digestive system. In contrast, conventional dietary advice, another approach in this trial, does not demonstrate the same level of improvement in these areas. Personalized nutrition programs have consistently outperformed standard advice, making them a promising approach for better heart health. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

Exclusion Criteria

You are currently pregnant or breastfeeding.

You have used illegal drugs.

I am not currently taking antibiotics.

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?

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+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised Nutrition: Updates, Gaps and Next Steps. Biesiekierski, JR., Livingstone, KM., Moschonis, G.[2020]

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]

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]

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]

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]

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]

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]

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]

Citations

1. nature.com nature.com/articles/s41591-024-02951-6

Effects of a personalized nutrition program on ... Overall, these findings suggest that a dietary program focused on personalized advice is more effective in reducing central adiposity and TG ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38714898/

Effects of a personalized nutrition program on cardiometabolic ... The personalized diet significantly reduced triglycerides and showed improvements in body weight, waist circumference, HbA1c, diet quality and microbiome.

3. news-medical.net news-medical.net/news/20240513/Personalized-dietary-programs-outperform-general-advice-for-better-heart-health.aspx

Personalized dietary programs outperform general advice ... Study found that personalized dietary programs (PDP) led to significant improvements in cardiometabolic health compared to standard dietary ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8224682/

A Novel Personalized Systems Nutrition Program Improves ... This study shows that a PSN program in a workforce improves lifestyle habits and reduces body weight, BMI and other health-related outcomes.

5. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/e1709/7825797

Do Personalized Nutrition Interventions Improve Dietary Intake ... Personalized nutrition (PN) shows potential benefits for systolic and diastolic blood pressure and dietary intake, especially with dietary ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1050173825001112

The role of nutrition in cardiovascular protection They lead to a decrease in major adverse CVD events, low-density lipoprotein cholesterol (LDL-C), blood pressure (BP), and systemic inflammation ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11357412/

Personalized Nutrition: Tailoring Dietary Recommendations ... Personalized nutrition (PN) represents a transformative approach in dietary science, where individual genetic profiles guide tailored dietary recommendations.