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.
Is personalized nutrition a promising treatment for health optimization?Yes, personalized nutrition is a promising treatment for health optimization. It uses individual differences to create tailored diet plans that can prevent and manage diseases, and improve overall health. By understanding how our genes and other factors affect our response to food, personalized nutrition can help people achieve better health outcomes.458911
What safety data exists for personalized nutrition treatments?The research does not provide specific safety data for personalized nutrition treatments. However, it highlights the need for scientific substantiation and regulatory frameworks to ensure consumer trust and safety. The concept of personalized nutrition is promising, but challenges remain in providing targeted advice and ensuring safe nutrient intake levels.2361012
What data supports the idea that Personalized Nutrition for Health Optimization is an effective treatment?The available research shows that Personalized Nutrition for Health Optimization can be effective because it tailors nutrition strategies to individual needs, which can help prevent, manage, and treat diseases. It emphasizes understanding how different factors like genetics and diet affect a person's health. This approach is more personalized compared to general nutrition advice, which may not work for everyone. The research also highlights the importance of training healthcare professionals to apply these personalized strategies effectively.147813
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, for Module 3, you must abstain from tobacco, nicotine, alcohol, and illicit drugs for two weeks while in the clinical unit. Chronic prescription medications that pose logistical and safety issues may also be a concern.
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.Exclusion Criteria
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 Uncontrolled disease states -- Hypertension >160/100mmHg; Exacerbation of underlying gastrointestinal disease, including inflammatory bowel disease or other malabsorptive disorders; Decompensated cirrhosis; Diabetes Mellitus with HbA1c >12% at screening; Newly diagnosed diabetes within the past three months or diagnosed diabetes mellitus at screening (HbA1c >6.5%); Participants with a history of end-stage renal disease (ESRD) on hemodialysis; Active infectious diseases (e.g., active tuberculosis < 3 months from symptom onset or positive test, COVID < 1 month from symptom onset or positive test); Malignancy (e.g., cancer) actively receiving cytotoxic chemotherapy (oral or infusions) treatment except for nonmelanoma skin cancers during the study period; Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases; Participants with Type 1 or Type 2 diabetes on insulin; Participants aged ≥ 75 years with Type 2 diabetes taking prescribed medications that can cause hypoglycemia (e.g. sulfonylureas, glinides), or on a prescribed diet; Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months; Requiring transfusions/apheresis during study period; Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years; Participants with major psychiatric disorders, including major depression, schizophrenia, or psychosis, who have been hospitalized in the past six (6) months or are currently enrolled in treatment programs; Anemia defined as point of care (POC) Hemoglobin <9.5 g/dL at screening; Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months; Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's opinion, might jeopardize the safety of the participant or others, or be expected to interfere with adherence to the protocol.
Treatment Details
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.
3Treatment groups
Experimental Treatment
Group I: Module 3Experimental Treatment5 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 2Experimental Treatment4 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 1Experimental Treatment1 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Tufts UniversityBoston, MA
Pennington Biomedical Research CenterBaton Rouge, LA
University of North Carolina at Chapel Hill - Nutrition Research Institute ClinicChapel Hill, NC
Louisiana State University Health Sciences CenterNew Orleans, LA
More Trial Locations
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Who is running the clinical trial?
RTI InternationalLead Sponsor
National Institutes of Health (NIH)Collaborator
University of North Carolina, Chapel HillCollaborator
Northwestern UniversityCollaborator
Illinois Institute of TechnologyCollaborator
University of ChicagoCollaborator
Pennington Biomedical Research CenterCollaborator
Louisiana State University Health Sciences Center in New OrleansCollaborator
University of California, DavisCollaborator
University of California, Los AngelesCollaborator
References
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]Different nutritional outcome studies on the same subject can have vast differences in composition of the chosen food without justification, suggesting that the composition of "optimal" nutrition in patients is not known or that optimal nutrition does not exist. The result will be negative studies which reinforces the existing impression that nutritional intervention is of limited value in every day's patient care. This perspective will put arguments forward that optimal nutrition exists and that the definition of optimal nutrition should be the base of future nutrition intervention studies. This perspective aims at providing a definition of optimal nutrition and consequently a basis to critically appraise the literature upon nutritional interventions in disease states.
Consumer demand for personalized nutrition and functional food. [2022]New developments in nutrigenetic research and the European regulation 1924/2006 on health claims have spurred interest in developing and marketing functional food designed for personalized nutrition. Personalized nutrition uses genetic information regarding a person's health risk profile. Specifically adapted nutrition recommendations are claimed to help reducing disease risk. An internet survey was conducted in December 2007 using a sample of 452 randomly selected adults in Germany. The survey instrument assesses if consumers would be willing to participate in genetic risk profiling, if they are interested in personalized nutrition advice and if they desire functional food products adapted to their individual nutrigenetic profile. In addition, we estimate the acceptance of functional food products designed to reduce the risk of cardio-vascular diseases. Consumers have a positive attitude towards the testing of their genetic profile to be used in nutrient advice. About 45 % of the sample would agree to such a test and like to obtain a personalized advice on nutrition. Similarly, more than 40 % of the sample showed a positive willingness to buy the proposed functional food products. Given these results, the concept of personalized nutrition seems promising. However, several challenges remain regarding targeted nutrition advice and food marketing.
Toxicity due to excess and deficiency. [2010]Customary approaches to setting safe upper levels for the intake of nutrients use, as critical events, adverse health that which, when adjusted using uncertainty factors (UF), produce values that, when they are applied to population risk analysis, along with dietary reference values that have been independently derived using a different approach by nutritionists, may provide narrow and unrealistic safe ranges of dietary intake. This study describes the evolving concept of the risk assessment of nutrients in which the critical events are based on homeostatic health effects that occur at the upper extreme of the physiological range of intakes. These events can be envisaged as markers of failing adaptation to high exposures and as heralds of potential later adverse events. Such markers may be associated with smaller and more easily characterized uncertainties than those applied to the more gross toxicological architectural, functional, or reproductive health effects used in standard toxicological risk assessment. The study also outlines the potential extension of this homeostatic model to the determination of safe lower limits of intake for essential nutrients and the identification, when homeostasis fails, of thresholds for inadequate intakes that can be adjusted by using uncertainty factors (UF) to derive adequate reference intakes.
Personalised Interventions-A Precision Approach for the Next Generation of Dietary Intervention Studies. [2018]Diet is a key modifiable risk factor for non-communicable diseases. However, we currently are not benefitting from the full potential of its protective effects. This is due to a number of reasons, including high individual variability in response to certain diets. It is now well acknowledged that in order to gain the full benefit of dietary regimes it is essential to take into account individual responses. With this in mind, the present review examines the concept of precision nutrition and the performance of n-of-1 studies, and discusses the development of certain approaches that will be critical for development of the concepts.
Systems biology of personalized nutrition. [2018]Personalized nutrition is fast becoming a reality due to a number of technological, scientific, and societal developments that complement and extend current public health nutrition recommendations. Personalized nutrition tailors dietary recommendations to specific biological requirements on the basis of a person's health status and goals. The biology underpinning these recommendations is complex, and thus any recommendations must account for multiple biological processes and subprocesses occurring in various tissues and must be formed with an appreciation for how these processes interact with dietary nutrients and environmental factors. Therefore, a systems biology-based approach that considers the most relevant interacting biological mechanisms is necessary to formulate the best recommendations to help people meet their wellness goals. Here, the concept of "systems flexibility" is introduced to personalized nutrition biology. Systems flexibility allows the real-time evaluation of metabolism and other processes that maintain homeostasis following an environmental challenge, thereby enabling the formulation of personalized recommendations. Examples in the area of macro- and micronutrients are reviewed. Genetic variations and performance goals are integrated into this systems approach to provide a strategy for a balanced evaluation and an introduction to personalized nutrition. Finally, modeling approaches that combine personalized diagnosis and nutritional intervention into practice are reviewed.
A Statistical Framework to Interpret Individual Response to Intervention: Paving the Way for Personalized Nutrition and Exercise Prescription. [2020]The concept of personalized nutrition and exercise prescription represents a topical and exciting progression for the discipline given the large inter-individual variability that exists in response to virtually all performance and health related interventions. Appropriate interpretation of intervention-based data from an individual or group of individuals requires practitioners and researchers to consider a range of concepts including the confounding influence of measurement error and biological variability. In addition, the means to quantify likely statistical and practical improvements are facilitated by concepts such as confidence intervals (CIs) and smallest worthwhile change (SWC). The purpose of this review is to provide accessible and applicable recommendations for practitioners and researchers that interpret, and report personalized data. To achieve this, the review is structured in three sections that progressively develop a statistical framework. Section 1 explores fundamental concepts related to measurement error and describes how typical error and CIs can be used to express uncertainty in baseline measurements. Section 2 builds upon these concepts and demonstrates how CIs can be combined with the concept of SWC to assess whether meaningful improvements occur post-intervention. Finally, section 3 introduces the concept of biological variability and discusses the subsequent challenges in identifying individual response and non-response to an intervention. Worked numerical examples and interactive Supplementary Material are incorporated to solidify concepts and assist with implementation in practice.
Charting the Course to Success in the Era of Personalized Nutrition. [2022]The personalized nutrition industry is quickly gaining scale, momentum, and consumer visibility. Health care practitioners must ready themselves to evaluate and utilize new products, services, and technologies, that will be required in order to responsibly enable their patients to benefit from this new era of precision medicine. This paper seeks to accomplish two objectives: (1) establish a perspective on the application of personalized nutrition in clinical practice in light of the current state of the industry ecosystem and the underlying science; and (2) propose a specific course of action for practitioners seeking to develop and deliver personalized nutrition services to patients.
Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]Personalized nutrition holds tremendous potential to improve human health. Despite exponential growth, the field has yet to be clearly delineated and a consensus definition of the term "personalized nutrition" (PN) has not been developed. Defining and delineating the field will foster standardization and scalability in research, data, training, products, services, and clinical practice; and assist in driving favorable policy. Building on the seminal work of pioneering thought leaders across disciplines, we propose that personalized nutrition be defined as: a field that leverages human individuality to drive nutrition strategies that prevent, manage, and treat disease and optimize health, and be delineated by three synergistic elements: PN science and data, PN professional education and training, and PN guidance and therapeutics. Herein we describe the application of PN in these areas and discuss challenges and solutions that the field faces as it evolves. This and future work will contribute to the continued refinement and growth of the field of PN.Teaching pointsPN approaches can be most effective when there is consensus regarding its definition and applications.PN can be delineated into three main areas of application: PN science and data, PN education and training, PN guidance and therapeutics.PN science and data foster understanding about the impact of genetic, phenotypic, biochemical and nutritional inputs on an individual's health.PN education and training equip a variety of healthcare professionals to apply PN strategies in many healthcare settings.PN professionals have greater ability to tailor interventions via PN guidance and therapeutics.Favorable policy allows PN to be more fully integrated into the healthcare system.
Molecular annotation of food - towards personalized diet and precision health. [2022]Personalized diet requires matching human genotypic and phenotypic features to foods that increase the chance of achieving a desired physiological health outcome. New insights and technologies will help to decipher the intricacies of diet-health relationships and create opportunities for breakthroughs in dietary interventions for personal health management.
What is the promise of personalised nutrition? [2022]Personalised nutrition (PN) is an emerging field that bears great promise. Several definitions of PN have been proposed and different modelling approaches have been used to claim PN effects. We tentatively propose to group these approaches into two categories, which we term outcome-based and population reference approaches, respectively. Understanding the fundamental differences between these two types of modelling approaches may allow a more realistic appreciation of what to expect from PN interventions presently and may be helpful for designing and planning future studies investigating PN interventions.
Nutrition for precision health: The time is now. [2022]Precision nutrition has emerged as a boiling area of nutrition research, with a particular focus on revealing the individual variability in response to diets that is determined mainly by the complex interactions of dietary factors with the multi-tiered "omics" makeups. Reproducible findings from the observational studies and diet intervention trials have lent preliminary but consistent evidence to support the fundamental role of gene-diet interactions in determining the individual variability in health outcomes including obesity and weight loss. Recent investigations suggest that the abundance and diversity of the gut microbiome may also modify the dietary effects; however, considerable instability in the results from the microbiome research has been noted. In addition, growing studies suggest that a complicated multiomics algorithm would be developed by incorporating the genome, epigenome, metabolome, proteome, and microbiome in predicting the individual variability in response to diets. Moreover, precision nutrition would also scrutinize the role of biological (circadian) rhythm in determining the individual variability of dietary effects. The evidence gathered from precision nutrition research will be the basis for constructing precision health dietary recommendations, which hold great promise to help individuals and their health care providers create precise and effective diet plans for precision health in the future.
Precision nutrition: Maintaining scientific integrity while realizing market potential. [2022]Precision Nutrition (PN) is an approach to developing comprehensive and dynamic nutritional recommendations based on individual variables, including genetics, microbiome, metabolic profile, health status, physical activity, dietary pattern, food environment as well as socioeconomic and psychosocial characteristics. PN can help answer the question "What should I eat to be healthy?", recognizing that what is healthful for one individual may not be the same for another, and understanding that health and responses to diet change over time. The growth of the PN market has been driven by increasing consumer interest in individualized products and services coupled with advances in technology, analytics, and omic sciences. However, important concerns are evident regarding the adequacy of scientific substantiation supporting claims for current products and services. An additional limitation to accessing PN is the current cost of diagnostic tests and wearable devices. Despite these challenges, PN holds great promise as a tool to improve healthspan and reduce healthcare costs. Accelerating advancement in PN will require: (a) investment in multidisciplinary collaborations to enable the development of user-friendly tools applying technological advances in omics, sensors, artificial intelligence, big data management, and analytics; (b) engagement of healthcare professionals and payers to support equitable and broader adoption of PN as medicine shifts toward preventive and personalized approaches; and (c) system-wide collaboration between stakeholders to advocate for continued support for evidence-based PN, develop a regulatory framework to maintain consumer trust and engagement, and allow PN to reach its full potential.
Nutrition issues in the general medical ward patient: From general screening to specific diagnosis and individualized treatment. [2023]Disease-related malnutrition in patients in the general medical ward remains a complex syndrome, which contributes to high morbidity and mortality, and seriously interferes with recovery from acute illness. Recently, there have been important advances in the development of consensus diagnostic criteria for malnutrition, and through the recent completion of large-scale trials, the understanding of pathophysiological pathways and evidence-based treatment algorithms to provide nutrition care to patients at risk for malnutrition in the hospital setting has advanced. There is need to identify more specific clinical parameters and blood biomarkers, which allow a more personalized approach to the malnourished patients, because not all patients show the same response to nutrition interventions. Recent studies have suggested that some nutrition biomarkers of inflammation, kidney function and muscle health, among others, predict treatment response to nutrition interventions and may help to personalize treatments. In addition to advancing the science, there is need for more education of students and treating teams in the hospital to improve the screening of patients at hospital admission regarding nutrition risk with the start of individualized nutrition support interventions, thereby bringing optimal nutrition care to the bedside.