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โ† Trials
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Nutrition for Precision Health, Powered by the All of Us

RecruitingNAAges 18 Years - anyAllRTI International
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In plain words

What the trial is, and whether it could suit you

The goal of this Nutrition for Precision Health (NPH) powered by All of Us research study is to develop Artificial Intelligence/Machine Learning (AI/ML) algorithms that predict individual responses to diet patterns using rich multimodal data streams collected across multiple domains (e.g., behavior, social, environmental, clinical and molecular biomarkers). NPH includes a large phenotyping cohort (Module 1, N=8000) and two separate follow-up groups drawn from a subset of Module 1participants. One group (Module 2, N=1200) receives three distinct diets in a 14-day crossover sequence, with at least a 14-day washout period between diets, while living in their own homes. A second group (Module 3, N=150) receives the same three diets under full-time supervision in a residential research setting. We will train and test AI/ML models to predict 0-4 hour postprandial response curves for glucose, i

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Overall Inclusion -- Participants 18 years of age or older who have completed the primary All of Us consent process, Electronic Health Record consent process, have provided at least one All of Us biospecimen suitable for DNA sequencing, and have completed All of Us Participant Provided Information (PPI) Modules 1-3 (Basics, Overall Health, and Lifestyle); Speak English or Spanish; Able and willing to comply with study requirements and consent to participate. * Module 1 -- Must be willing and able to comply with Module 1 protocol; Must provide informed consent for Module 1. * Module 2 -- Must have completed Module 1; Must provide informed consent for Module 2; Must agree to comply with protocol over a period of approximately 10 to 12 weeks and up to six months. This includes consuming only the foods provided during periods of controlled feeding. Module 2 has three controlled feeding periods each lasting approximately two weeks with at least two weeks between feeding periods, and up to 6 months allowed for completion of the Module. * Module 3 -- Must have completed Module 1; Must provide informed consent for Module 3; Must agree to comply with protocol over a period of approximately 10 to 12 weeks and up to 6 months. This includes being domiciled three times, for two weeks each, and consuming only the foods provided during the domiciled periods. There is at least two weeks between domiciled periods, and up to 6 months allowed for completion of the Module. Exclusion Criteria: * Module 1 1. 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). 2. Inability to provide informed consent and engage in informed consent procedures 3. Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the liquid mixed meal (e.g., milk products, soy products) 4. Barriers to safe insertion of peripheral IV canula: 1. Contraindications to peripheral IV canula insertion such as local skin infection, inflammation, trauma or burns if all the upper extremities were involved and there is no unaffected extremity available for IV placement; or 2. A need for long-term IV access (e.g., ESRD); or 3. Lymphedema or deep vein thrombosis (DVT) in the extremity of the IV (in the case where another extremity is not available); or 4. Coagulopathy requiring blood thinning products; or 5. Arteriovenous (AV) graft or fistula in the extremity of the IV (in the case where another extremity is not available) 5. Pregnancy-related conditions: 1. Gestational age precluding completion of the Module by 36 weeks. A pregnant participant should complete visit 1 by gestational age 34 weeks, 0 days and complete Module 1 by week 36. 2. Severe morning sickness limiting mixed meal tolerance test (MMTT) consumption 6. Certain types of disease states: 1. Dumping syndrome or inability to consume the volume of the MMTT liquid 2. Severe malabsorption such as history of short gut syndrome or need for parenteral or enteral nutrition 3. Less than 12-months post-metabolic or bariatric surgery 4. History of chronic pancreatitis (e.g., Cystic fibrosis) complicated by inability to tolerate the volume of the MMTT liquid 5. Health conditions requiring chronic blood transfusions or iron infusions 6. Hemoglobin \<9.5 g/dL at screening 7. Serious illness and in hospice or palliative care for terminal disease 8. Swallowing issues: 1. Self-reported difficulty tolerating solids or liquids 2. Aspiration risks that require change in thickness of liquid or dietary modifications 9. Short term antibiotic use. For example, active antibiotics use for an ongoing acute infection 10. Blood donation in the last 3 months 11. GLP-1 agonist medication (e.g. Semaglutide) instability as defined by less than 3 months of continuous use 12. Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol. * Module 2 1. 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) 2. All the above mentioned exclusion criteria for Module 1 (except inability to consume components of the liquid mixed meal) 3. Inability to provide informed consent and engage in informed consent procedures 4. Inability or failure to complete all critical elements from Module 1 (dietary, physical activity and sleep assessments, continuous glucose monitoring, MMTT) 5. Participants who are already enrolled in Module 3 6. 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. This includes participants who have known allergic reactions to, or unwillingness to consume, study foods in Module 2 (e.g., gluten, meat, fish, nuts, dairy products) that cannot be reasonably accommodated by the metabolic kitchen within allowable criteria for the test diets. 7. Participants who plan to relocate to an area not served by NPH or travel plans that do not permit completion of the Module over a period of up to 6 months. 8. Pregnancy-related conditions: 1. Gestational age precluding completion of the Module by week 36. A pregnant participant must be able to begin the first diet by gestational age 26 weeks, 0 days and complete the Module by week 36. 2. High risk pregnancy defined as fetal anomaly, gestational hypertension (SBP \>140 mmHg and DBP \>90 mmHg), pre-eclampsia, or gestational diabetes mellitus 9. Possible ethanol (alcohol)
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What it tests

  • Diet A
  • Diet B
  • Diet C
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Where

14 sites
University of Alabama at Birmingham
Birmingham, United States
University of California, Davis
Davis, United States
USDA Western Human Nutrition Research Center
Davis, United States
University of California, Los Angeles
Los Angeles, United States
Cedars Sinai Medical Center
West Hollywood, United States
Northwestern University
Chicago, United States
Illinois Institute of Technology
Chicago, United States
University of Chicago
Chicago, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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