Personalized Nutrition for Health Optimization

Recruiting at 16 trial locations

Overseen By Joyce Ho, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Must not be taking: GLP-1 agonists, Insulin, Sulfonylureas, Glinides

Disqualifiers: Pregnancy, Diabetes, Cancer, Hypertension, others

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

Compensation: Varies

Number of Visits: 8

8000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different foods and eating patterns affect health using advanced technology, such as artificial intelligence. Researchers will examine how various diets impact people's bodies and develop methods to recommend personalized nutrition plans, known as Nutrition for Precision Health. Participants may join one of three modules, each offering different levels of dietary monitoring and intervention. This trial suits individuals in the All of Us research program who can adhere to specific diet plans and do not have certain food allergies or medical conditions affecting digestion. As an unphased trial, it offers a unique opportunity to contribute to cutting-edge research in personalized nutrition.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that chronic prescription medications posing logistical and safety issues may be a concern, so it's best to discuss your specific medications with the study team.

What prior data suggests that this investigational study is safe?

Research shows that personalized nutrition, also known as precision nutrition, is gaining popularity in health studies. The goal is to tailor dietary advice to each person's needs. This study does not involve new drugs or medical procedures, which generally increases its safety.

In similar studies, participants tried different diets and researchers monitored changes in their health. These studies usually find that most people handle dietary changes well, with few side effects. Participants often notice changes in weight, blood sugar levels, or other health indicators, which are typically expected when altering diets.

Since this study examines reactions to different foods, following the given instructions and sharing any concerns with the study team is important. If dietary changes affect participants, the study team can provide assistance. Overall, personalized nutrition is considered safe because it focuses on dietary changes rather than new medicines or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Nutrition for Health Optimization trial because it aims to tailor dietary interventions to individual needs, unlike the one-size-fits-all approach of current nutrition guidelines. This trial stands out due to its use of continuous glucose monitoring and accelerometers to gather real-time data on participants' responses to different diets. By collecting a variety of biospecimens, including blood, urine, and stool samples, the trial provides a comprehensive view of how personalized diets could optimize health. These innovative methods could lead to more effective and individualized dietary recommendations, potentially revolutionizing how we approach nutrition and health.

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

Research shows that personalized nutrition can help people create diet plans tailored to their unique needs. Studies have found that individuals react differently to various foods, so a single diet plan might not suit everyone. The Nutrition for Precision Health study, which includes different modules as treatment arms, aims to develop tools that predict how different foods will affect each person. Early results suggest that combining artificial intelligence with dietary information can lead to more personalized and effective diet advice. By understanding these reactions, individuals can make better food choices to improve their health. ^{1 2 3 4 6}

Who Is on the Research Team?

Marie G Gantz, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

Adults over 18 who've consented to the All of Us study, provided biospecimens for DNA sequencing, and completed certain health modules. They must speak English or Spanish and follow the study's diet-only protocol for up to 6 months. Excluded are those with uncontrolled diseases like severe hypertension, diabetes, infectious diseases; dietary restrictions due to medical conditions; recent major surgeries or hospitalizations; substance abuse issues; and pregnant women beyond a certain gestational stage.

Inclusion Criteria

You must have finished Module 1 and agree to follow the study rules for Module 2, which lasts about 10 to 12 weeks (up to 6 months). During this time, you can only eat the food provided in the controlled feeding periods, which happen three times for two weeks each with at least two weeks break in between.

You must agree to follow the instructions for Module 1 of the study and give your permission to participate.

You have already completed Module 1 and provided consent for Module 3. You must agree to follow the study's plan for about 10 to 12 weeks and be willing to stay at a designated location for two weeks, three times during the study. You will only eat the provided foods during these stays, and there will be at least two weeks between each stay. The entire module may take up to 6 months to complete.

Exclusion Criteria

I've had surgery for obesity and experience dumping syndrome or follow a special diet.

Module 1 Pregnancy-related conditions -- Gestational age precluding completion of the Module by 36 weeks; Severe morning sickness limiting mixed meal tolerance test (MMTT) consumption.

Module 1 Certain types of disease states -- Dumping syndrome or inability to consume 400 mL of liquid; Severe malabsorption such as history of short gut syndrome or need for parenteral or enteral nutrition; Less than 12-months post-metabolic or bariatric surgery; History of chronic pancreatitis (e.g., Cystic fibrosis) complicated by inability to tolerate 400 mL of fluid; Anemia requiring chronic blood transfusions or iron infusions; Anemia defined as point of care (POC) Hemoglobin <9.5 g/dL at screening; Serious illness and in hospice or palliative care for terminal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Module 1

Participants' dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, including physiological responses to a liquid mixed meal tolerance test.

8-10 days

2 visits (in-person), remote data collection

Module 2

Participants undergo three controlled dietary interventions for 14 days each, separated by washout periods of at least 14 days, with physiological responses measured.

10 weeks

6 visits (in-person)

Module 3

Similar to Module 2, but participants are studied in-residence during the dietary interventions.

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition for Precision Health

Trial Overview The trial is testing how different diets (Diet A, B, C) affect biological responses by observing participants' nutritional intake and reactions to specific meal tolerance tests. It uses AI and machine learning to predict food effects on health. Participants may join one of three modules involving controlled diets and in-residence stays for comprehensive monitoring.

How Is the Trial Designed?

Group I: Module 3 Experimental Treatment 5 Interventions

Module 3 is a minimum of 10 weeks long. It includes three (3), 14-day dietary interventions (i.e. Diets A, B, and C) completed while participants are domiciled under the supervision of study staff. At the end of each dietary intervention period, participants return to their usual residence and routine for a minimum of 2 weeks. At the beginning of each diet period, anthropometry (weight and circumferences), vital signs (temperature, respiratory rate and blood pressure) and body composition by BIA and DXA, and physical measures will be measured. Biospecimens (blood, urine and saliva) will be collected. An accelerometer and a continuous glucose monitoring device will be applied. Excluding pregnant females, participants will receive a dose of doubly labeled water. Weight and vital signs will be measured daily and questionnaires administered. A diet-specific MMTT and a separate liquid MMTT with timed blood biospecimen collection and visual analogue assessments will be completed.

Group II: Module 2 Experimental Treatment 4 Interventions

Module 2 is a minimum of 10 weeks long. It includes a total of six (6) study visits that occur before and after each of the three (3), 14-day dietary intervention periods (i.e., Diets A, B, and C), separated by washout periods of at least 14 days. Participants will be asked to consume only the foods provided and to adhere to their other usual routines throughout the study. At the beginning of each diet period, anthropometry (weight and circumferences), vital signs (temperature, respiratory rate and blood pressure) and body composition by BIA will be measured. Biospecimens (blood, urine and saliva) will be collected. An accelerometer and a continuous glucose monitoring device will be applied for remote data collection. A stool sample collection kit will be provided together with instructions for stool collection and dietary assessments. At the end of each diet, a diet-specific meal test with timed biospecimen blood collection and visual analogue assessments will be completed.

Group III: Module 1 Experimental Treatment 1 Intervention

Module 1 is approximately 10 days (minimum of 8 days) and includes two study visits and remote data collection. Visit 1 will include application of an accelerometer and continuous glucose monitoring device for remote data collection over the next 8 to 10 days. A stool sample collection kit and instructions for stool collection and completion of dietary assessments during the observation period will be provided. At Visit 2, anthropometry (height, weight and body circumferences), body composition by bioelectrical impedance (BIA), vital signs (temperature, respiratory rate and blood pressure), and grip strength will be measured. Medications will be recorded. A liquid MMTT with timed biospecimen collection (blood, urine, saliva, hair, and nails) and visual analogue assessments will be completed. Participants in Module 1 will be asked to adhere to their usual routine (e.g., diet, exercise, sleep, supplements, medication use, etc.) throughout the study.

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

Stevens Institute of Technology

Collaborator

Trials

5

Recruited

8,700+

United States Military Academy West Point

Collaborator

Trials

3

Recruited

108,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Illinois Institute of Technology

Collaborator

Trials

26

Recruited

15,300+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

Published Research Related to This Trial

Diet plays a crucial role in reducing the risk of non-communicable diseases, but individual responses to diets can vary significantly, limiting their effectiveness.

The review emphasizes the importance of precision nutrition and n-of-1 studies, which tailor dietary recommendations to individual responses, to maximize the health benefits of dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised Interventions-A Precision Approach for the Next Generation of Dietary Intervention Studies. de Roos, B., Brennan, L.[2018]

This review emphasizes the importance of personalized nutrition and exercise prescriptions due to the significant variability in individual responses to health interventions, highlighting the need for tailored approaches.

It provides a statistical framework for practitioners to interpret and report personalized data, focusing on measurement error, confidence intervals, and biological variability to better assess the effectiveness of interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Statistical Framework to Interpret Individual Response to Intervention: Paving the Way for Personalized Nutrition and Exercise Prescription. Swinton, PA., Hemingway, BS., Saunders, B., et al.[2020]

The personalized nutrition industry is rapidly evolving, and healthcare practitioners need to adapt by understanding and utilizing new products and technologies to help patients benefit from precision medicine.

While true 'n of 1' personalization is still a goal, practitioners can currently enhance patient care by using available testing methods to group patients by common diagnoses and employing digital health tracking to refine nutrition and lifestyle prescriptions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Charting the Course to Success in the Era of Personalized Nutrition. Blue, T.[2022]

Personalized nutrition (PN) is a promising field that aims to tailor dietary recommendations to individual needs, but it currently lacks a unified definition and consistent modeling approaches.

The authors propose categorizing PN modeling into two types: outcome-based and population reference approaches, which could enhance understanding and expectations of PN interventions and aid in designing future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the promise of personalised nutrition? Ferrario, PG., Watzl, B., Møller, G., et al.[2022]

Recent advances in diagnosing disease-related malnutrition in hospitalized patients have led to better understanding of its impact on recovery and the development of evidence-based treatment algorithms.

Identifying specific clinical parameters and blood biomarkers can help personalize nutrition interventions, improving outcomes for malnourished patients, and emphasizing the need for better education on nutrition risk screening in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition issues in the general medical ward patient: From general screening to specific diagnosis and individualized treatment. Gressies, C., Tribolet, P., Schuetz, P.[2023]

Personalized nutrition is becoming more feasible due to advancements in technology and science, allowing dietary recommendations to be tailored to individual health needs and goals.

A systems biology approach is essential for creating effective personalized nutrition plans, as it considers the complex interactions between biological processes, nutrients, and environmental factors, enabling real-time adjustments to dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systems biology of personalized nutrition. van Ommen, B., van den Broek, T., de Hoogh, I., et al.[2018]

Precision Nutrition (PN) tailors dietary recommendations based on individual factors like genetics, health status, and lifestyle, recognizing that dietary needs can vary greatly from person to person.

Despite its potential to enhance health and reduce healthcare costs, challenges such as high costs of diagnostic tests and a lack of scientific backing for many current products hinder the widespread adoption of PN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision nutrition: Maintaining scientific integrity while realizing market potential. Berciano, S., Figueiredo, J., Brisbois, TD., et al.[2022]

This study proposes a new approach to setting safe upper limits for nutrient intake by focusing on homeostatic health effects rather than just adverse health events, which may lead to more realistic dietary intake recommendations.

The authors suggest that this homeostatic model could also help determine safe lower limits for essential nutrients, allowing for better identification of thresholds for inadequate intakes and improving dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity due to excess and deficiency. Aggett, PJ.[2010]

A survey of 452 adults in Germany revealed that about 45% are open to genetic testing for personalized nutrition advice, indicating a strong interest in tailored dietary recommendations based on individual health risks.

Over 40% of participants expressed a willingness to purchase functional food products designed to reduce cardiovascular disease risk, suggesting a promising market for personalized nutrition solutions, although challenges in implementation remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer demand for personalized nutrition and functional food. Roosen, J., Bruhn, M., Mecking, RA., et al.[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]

Current nutritional outcome studies often lack consistency in food composition, leading to confusion about what constitutes 'optimal' nutrition for patients.

Establishing a clear definition of optimal nutrition is essential for future studies, as it could improve the understanding and effectiveness of nutritional interventions in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: How to evaluate studies on peri-operative nutrition? Considerations about the definition of optimal nutrition for patients and its key role in the comparison of the results of studies on nutritional intervention. Sauerwein, HP., Strack van Schijndel, RJ.[2008]

Personalized diets aim to match individual genetic and physical traits with specific foods to improve health outcomes, emphasizing the need for high-quality data on food properties.

A framework for molecular annotation of food is proposed, which includes analyzing its chemical composition and biological properties, and leveraging technologies like omics and AI to enhance personalized dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular annotation of food - towards personalized diet and precision health. Gan, J., Siegel, JB., German, JB.[2022]

Precision nutrition research highlights that individual responses to diets can vary significantly due to interactions between dietary factors and personal genetic makeups, which has implications for health outcomes like obesity and weight loss.

Emerging studies suggest that a comprehensive multiomics approach, including factors like the gut microbiome and biological rhythms, could enhance the prediction of how individuals respond to different diets, paving the way for personalized dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition for precision health: The time is now. Qi, L.[2022]

Citations

1. commonfund.nih.gov commonfund.nih.gov/nutritionforprecisionhealth

Nutrition for Precision Health, powered by the All of Us ... High-quality nutrition studies such as the NPH study will help individuals and their health care providers create healthy, precise, and effective diet plans.

2. nutritionforprecisionhealth.org nutritionforprecisionhealth.org/

Nutrition for Precision Health The Nutrition for Precision Health study is trying to answer this question by studying how individual people respond to different foods. Nutrition for Precision ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05701657

Nutrition for Precision Health, Powered by the All of Us The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are:.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000134

Data in Personalized Nutrition: Bridging Biomedical ... This perspective proposes a comprehensive framework for Personalized Nutrition (PN) that integrates biomedical, psycho-behavioral, and environmental data

5. nature.com nature.com/articles/d42473-025-00199-3

Advancing precision nutrition for better health Researchers are exploring comprehensive tools and dietary approaches to deliver precise nutritional support and help people live healthier lives.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11397555/

Precision or Personalized Nutrition: A Bibliometric Analysis The practice of personalized or precision nutrition is currently growing in popularity as one of the best ways to improve the health of ...