Personalized Nutrition for Health Optimization

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen by Marie G Gantz, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: RTI International

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

Disqualifiers: Pregnancy, Diabetes, Cancer, Hypertension, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: * How does varying foods and eating patterns impact one's biological and physiological responses? * In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? * Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: * Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. * Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. * Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured.

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 data supports the effectiveness of the treatment Nutrition for Precision Health, Personalized Nutrition, Precision Nutrition?

Research suggests that personalized nutrition, which tailors dietary strategies to individual needs, can improve health by considering genetic and biochemical factors. This approach has shown potential in managing and preventing diseases by optimizing nutrition based on personal health data. ^{1 2 3 4 5}

Is personalized nutrition safe for humans?

The research on personalized nutrition does not specifically address safety concerns, but it emphasizes the need for scientific evidence to support its claims. Personalized nutrition aims to tailor dietary recommendations based on individual factors, which suggests a focus on health optimization rather than harm. ^{6 7 8 9 10}

How does personalized nutrition differ from other treatments for health optimization?

Personalized nutrition is unique because it tailors dietary recommendations to an individual's specific genetic, phenotypic, and biochemical characteristics, unlike standard treatments that often use a one-size-fits-all approach. This method considers the complex interactions between diet and a person's unique biological makeup, including their gut microbiome, to optimize health outcomes. ^{1 5 11 12 13}

Research Team

Marie G Gantz, PhD

Principal Investigator

RTI International

Eligibility Criteria

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

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.

Module 2 -- Any change to the participant's status from the time of All of Us enrollment that would render them ineligible for All of Us (e.g., being incarcerated, no longer living in the United States, or withdrawn from that study); Inability to provide informed consent and engage in informed consent procedures; Inability or failure to complete all critical elements from Module 1 (dietary, physical activity and sleep assessments, continuous glucose monitoring, MMTT); Participants who are already enrolled in Module 3; Participants who are unlikely to be able to adhere to the protocol, based on structured adherence assessment by a study registered dietitian or other trained staff.

Trial Timeline

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

Treatment Details

Interventions

• Nutrition for Precision Health (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Anuja Purohit

RTI International

Chief Medical Officer

MD from Duke University School of Medicine

Tim J. Gabel

RTI International

Chief Executive Officer since 2022

Adjunct appointments at University of Wyoming and UNC Gillings School of Global Public Health

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+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Illinois Institute of Technology

Collaborator

Trials

26

Recruited

15,300+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

Dr. Frank Greenway

Pennington Biomedical Research Center

Chief Medical Officer since 2024

MD from an accredited institution

Dr. John Kirwan

Pennington Biomedical Research Center

Chief Executive Officer since 2023

PhD in Molecular Medicine from Cleveland Clinic

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

J. Christian Winters

Louisiana State University Health Sciences Center in New Orleans

Chief Executive Officer

MD

Jayne Weiss

Louisiana State University Health Sciences Center in New Orleans

Chief Medical Officer

MD

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

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

2. England 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. [2008]

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

Nutrition issues in the general medical ward patient: From general screening to specific diagnosis and individualized treatment. [2023]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Personalised Interventions-A Precision Approach for the Next Generation of Dietary Intervention Studies. [2018]

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

Precision nutrition: Maintaining scientific integrity while realizing market potential. [2022]

7. England pubmed.ncbi.nlm.nih.gov

What is the promise of personalised nutrition? [2022]

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

Toxicity due to excess and deficiency. [2010]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Statistical Framework to Interpret Individual Response to Intervention: Paving the Way for Personalized Nutrition and Exercise Prescription. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Consumer demand for personalized nutrition and functional food. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Molecular annotation of food - towards personalized diet and precision health. [2022]

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

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

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

Systems biology of personalized nutrition. [2018]