Nutrition for Precision Health, Powered by the All of Us Research Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 23
- 主要终点
- Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet A
研究概览
简要总结
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, insulin, triglycerides, and GLP-1, to the standardized diet-specific meal test (DSMT) collected after each of the three different diets delivered in Module 2. Each diet functions as a controlled stimulus to reveal biological features (such as individual variables, patterns, or clusters of measurements) that best predict a person's response.
The Module 2 DSMT response curves are the primary outcomes (dependent variables) for AI/ML algorithms that predict individual responses to diet patterns.
As a secondary objective, NPH will evaluate the validity and acceptability of technology-based dietary assessment tools. The Automated Self-Administered 24-hour recall (ASA24), Automatic Ingestion Monitor-2 (AIM-2), and the mobile food record (mFR) will be evaluated in Modules 2 and 3, and the ASA24 food record and the image-assisted ASA24 recall will be evaluated only in Module 3. Total energy intake, macronutrient and dietary fiber intake data are the main outcomes for validity testing compared against measures of actual intake. Acceptability will be determined from feedback surveys.
详细描述
The Nutrition for Precision Health (NPH) study is a multi-module, large-scale project with observational and interventional components embedded in the All of Us Research Program. The overarching goal is to develop artificial intelligence and machine learning (AI/ML) algorithms that predict individual responses to different diet patterns. The study consists of three modules designed to balance breadth (large scale phenotyping) and depth (controlled dietary interventions):
Module 1: Phenotyping (non-interventional)
Module 2: Community-dwelling controlled feeding group (Intervention arm 1)
Module 3: Residential (Live-in) controlled feeding group (Intervention arm 2)
Approximately 8,000 participants are anticipated to be enrolled in Module 1. From this cohort, approximately 1,200 participants will enroll in Module 2, and a separate subset of Module 1 participants (approximately 150 participants) will enroll in Module 3. Module 1 is observational and only Modules 2 and 3 are interventional in nature (intervention arms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants are masked to the 3 different diets (i.e., Diet A, Diet B, Diet C).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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
- •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)
- •Barriers to safe insertion of peripheral IV canula:
- •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
- •A need for long-term IV access (e.g., ESRD); or
- •Lymphedema or deep vein thrombosis (DVT) in the extremity of the IV (in the case where another extremity is not available); or
- •Coagulopathy requiring blood thinning products; or
- •Arteriovenous (AV) graft or fistula in the extremity of the IV (in the case where another extremity is not available)
- •Pregnancy-related conditions:
- •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
- •Severe morning sickness limiting mixed meal tolerance test (MMTT) consumption
- •Certain types of disease states:
- •Dumping syndrome or inability to consume the volume of the MMTT 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 the volume of the MMTT liquid
- •Health conditions requiring chronic blood transfusions or iron infusions
- •Hemoglobin <9.5 g/dL at screening
- •Serious illness and in hospice or palliative care for terminal disease
- •Swallowing issues:
- •Self-reported difficulty tolerating solids or liquids
- •Aspiration risks that require change in thickness of liquid or dietary modifications
- •Short term antibiotic use. For example, active antibiotics use for an ongoing acute infection
- •Blood donation in the last 3 months
- •GLP-1 agonist medication (e.g. Semaglutide) instability as defined by less than 3 months of continuous use
- •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.
- •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)
- •All the above mentioned exclusion criteria for Module 1 (except inability to consume components of the liquid mixed meal)
- •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. 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.
- •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.
- •Pregnancy-related conditions:
- •Gestational age precluding completion of the Module by week
- •A pregnant participant must be able to begin the first diet by gestational age 26 weeks, 0 days and complete the Module by week
- •High risk pregnancy defined as fetal anomaly, gestational hypertension (SBP >140 mmHg and DBP >90 mmHg), pre-eclampsia, or gestational diabetes mellitus
- •Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of >15
- •History of surgery for the treatment of obesity and:
- •Self-reported dumping syndrome; or
- •Following a special diet prescribed by their practitioner
- •Uncontrolled disease states:
- •Hypertension >160/100mmHg
- •Exacerbation of underlying gastrointestinal disease, including inflammatory bowel disease or other malabsorptive disorders
- •Decompensated cirrhosis
- •Previously diagnosed diabetes Mellitus with HbA1c >12% at screening
- •Newly diagnosed diabetes within the past three months, or HbA1c >6.5% at screening in a person not previously diagnosed with diabetes.
- •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)
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研究组 & 干预措施
Residential Controlled-Feeding Arm (Module 3)
A separate group of participants drawn from Module 1, who are not enrolled in Module 2, will receive the same three standardized diets administered in Module 2 while residing in a fully supervised residential setting. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. Each diet period will last approximately 14 days and will be separated by washout periods of at least 14 days. Intake, activity, and sleep will be closely monitored. Participants will also complete the same liquid meal test administered in Module 1 (see detailed description) after each of the diet periods. A wealth of measurements will be collected, including data from wearables, physical and contextual measures, and biospecimens. Intake balance studies are conducted in this module using the doubly labeled water assessments and DXA for body composition. Module 3 is designed to isolate the response to different diets from behavioral variability observed in community settings.
干预措施: Diet B (Other)
Residential Controlled-Feeding Arm (Module 3)
A separate group of participants drawn from Module 1, who are not enrolled in Module 2, will receive the same three standardized diets administered in Module 2 while residing in a fully supervised residential setting. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. Each diet period will last approximately 14 days and will be separated by washout periods of at least 14 days. Intake, activity, and sleep will be closely monitored. Participants will also complete the same liquid meal test administered in Module 1 (see detailed description) after each of the diet periods. A wealth of measurements will be collected, including data from wearables, physical and contextual measures, and biospecimens. Intake balance studies are conducted in this module using the doubly labeled water assessments and DXA for body composition. Module 3 is designed to isolate the response to different diets from behavioral variability observed in community settings.
干预措施: Diet C (Other)
Community-Dwelling Controlled-Feeding Arm (Module 2)
Participants drawn from Module 1 will receive three standardized diets (A, B, and C) in one of six sequences. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. All meals are provided while participants remain living in their own homes. Each diet period lasts ~14 days, separated by washouts of at least 14 days. Participants are masked to the nutritional content of each diet. Data collection includes wearable device outputs, physical and contextual assessments, and biospecimens. This arm evaluates metabolic responses to controlled diets under real-world, community-dwelling conditions.
干预措施: Diet A (Other)
Community-Dwelling Controlled-Feeding Arm (Module 2)
Participants drawn from Module 1 will receive three standardized diets (A, B, and C) in one of six sequences. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. All meals are provided while participants remain living in their own homes. Each diet period lasts ~14 days, separated by washouts of at least 14 days. Participants are masked to the nutritional content of each diet. Data collection includes wearable device outputs, physical and contextual assessments, and biospecimens. This arm evaluates metabolic responses to controlled diets under real-world, community-dwelling conditions.
干预措施: Diet B (Other)
Residential Controlled-Feeding Arm (Module 3)
A separate group of participants drawn from Module 1, who are not enrolled in Module 2, will receive the same three standardized diets administered in Module 2 while residing in a fully supervised residential setting. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. Each diet period will last approximately 14 days and will be separated by washout periods of at least 14 days. Intake, activity, and sleep will be closely monitored. Participants will also complete the same liquid meal test administered in Module 1 (see detailed description) after each of the diet periods. A wealth of measurements will be collected, including data from wearables, physical and contextual measures, and biospecimens. Intake balance studies are conducted in this module using the doubly labeled water assessments and DXA for body composition. Module 3 is designed to isolate the response to different diets from behavioral variability observed in community settings.
干预措施: Diet A (Other)
Community-Dwelling Controlled-Feeding Arm (Module 2)
Participants drawn from Module 1 will receive three standardized diets (A, B, and C) in one of six sequences. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. All meals are provided while participants remain living in their own homes. Each diet period lasts ~14 days, separated by washouts of at least 14 days. Participants are masked to the nutritional content of each diet. Data collection includes wearable device outputs, physical and contextual assessments, and biospecimens. This arm evaluates metabolic responses to controlled diets under real-world, community-dwelling conditions.
干预措施: Diet C (Other)
结局指标
主要结局
Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet A
时间窗: 4 hours
Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet A.
Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet A
时间窗: 4 hours
Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet A.
Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet A
时间窗: 4 hours
Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet A.
GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet A
时间窗: 4 hours
Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet A.
Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet B
时间窗: 4 hours
Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet B.
Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet B
时间窗: 4 hours
Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet B.
Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet B
时间窗: 4 hours
Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet B.
GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet B
时间窗: 4 hours
Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet B.
Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet C
时间窗: 4 hours
Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet C.
Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet C
时间窗: 4 hours
Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet C.
Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet C
时间窗: 4 hours
Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet C.
GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet C
时间窗: 4 hours
Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet C.
次要结局
- Accuracy of energy intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to known intake from objective measures.(14 days)
- Accuracy of energy intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.(14 days)
- Accuracy of carbohydrate intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.(14 days)
- Accuracy of protein intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.(14 days)
- Accuracy of fat intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.(14 days)
- Accuracy of dietary fiber intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.(14 days)
- Acceptability scales for ASA24 and Diet A(14 days)
- Acceptability scales for ASA24 and Diet B(14 days)
- Acceptability scales for ASA24 and Diet C(14 days)
- Acceptability scales for mFR and Diet A(14 days)
- Acceptability scales for mFR and Diet B(14 days)
- Acceptability scales for mFR and Diet C(14 days)
- Acceptability scales for AIM-2 and Diet A(14 days)
- Acceptability scales for AIM-2 and Diet B(14 days)
- Acceptability scales for AIM-2 and Diet C(14 days)
- Acceptability scales for ASA24 Record and Diet A(14 days)
- Acceptability scales for ASA24 Record and Diet B(14 days)
- Acceptability scales for ASA24 Record and Diet C(14 days)
- Acceptability scales for mFR+ASA24 and Diet A(14 days)
- Acceptability scales for mFR+ASA24 and Diet B(14 days)
- Acceptability scales for mFR+ASA24 and Diet C(14 days)