이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

우리 모두가 제공하는 정밀 건강을 위한 영양

2026년 10월 7일 업데이트: RTI International

All of Us 연구 프로그램이 제공하는 정밀 건강을 위한 영양

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.

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
모병

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

상세 설명

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).

Module 1 is a phenotyping observational study. Participants undergo comprehensive characterization across an 8 to 10-day baseline period for assessments including: clinical measures, biospecimen collection, wearable sensor monitoring, questionnaires, and a liquid meal test (LMT). During the LMT, participants ingest a standardized liquid meal with a dose of acetaminophen for estimating gastric emptying and provide timed blood samples for postprandial profiling. The LMT is a diagnostic stimulus used solely for feature generation and is not being evaluated as an intervention. The resulting Module 1 high dimensional dataset supports machine learning methods (e.g., PCA, clustering, recursive feature elimination) for candidate predictor discovery and is therefore not listed in the Arms/Interventions section. Module 1 data will be used to develop novel statistical and machine learning methods to learn individual and generalizable causal models of nutrition and health, particularly in the presence of missing or incomplete data. The scale of Module 1 enables discovery of causal pathways and moderators between physical and contextual measures, LMT responses, and continuous glucose monitoring (CGM) data. These insights are critical for developing models that not only predict individual dietary responses but also explain why and under what conditions they occur.

Module 2 is a community dwelling controlled feeding arm (Intervention arm 1). A subset of Module 1 participants will enroll in Module 2, in which participants consume three standardized eucaloric diets; Diet A, Diet B, Diet C, in a crossover sequence. Each diet period lasts 12-14 days, separated by a minimum of 14-day washout period between diets. All meals are provided, but participants remain in their community dwelling environments. Participants undergo one of six possible sequences of dietary interventions, reflecting all possible orderings of the three diets (ABC, ACB, BCA, BAC, CAB, and CBA). To reduce potential bias, all six diet sequences are included in the crossover design. Rather than assigning diet sequences to individual participants, a cohort-based randomization approach is used to reduce operational burden on the metabolic kitchens. In this approach, pre-generated schedules involving all 6 diet sequences are randomly assigned to the clinical site metabolic kitchens, with each diet sequence corresponding to a cohort. Participants are then enrolled into the cohorts. The six diet orders are repeated over time at each site until the full enrollment targets for Modules 2 and 3 are met. Each site follows a different randomized version of the overall cohort schedule, which ensures distribution of the possible diet orders across time and clinical sites while preserving balance and logistical feasibility. Wearable-generated data (like accelerometry and CGM), physical and contextual measures are collected throughout.

At the completion of each diet participants are provided a standardized breakfast meal test, DSMT, from each of the three provided diets (Diet A, B, C). The 0-4 hour postprandial response curves are then used to evaluate inter-individual variation and unmask features collected in Module 1 and 2 that contribute to the AI/ML predictions of the response.

Each breakfast serves as a controlled stimulus to reveal underlying biological features from rich multimodal data streams, including clinical, molecular, behavioral, environmental, and social domains that may drive interindividual variability in metabolic response. For each DSMT, participants provide blood samples for up to nine time points over four hours. Analyte concentrations of glucose, insulin, triglycerides, and GLP-1, are used to construct response curves. The primary outcomes are the area under the curve (AUC) for each analyte (glucose, insulin, triglycerides, GLP-1) following each DSMT. This approach parallels a cardiac stress test: the stimulus (the meal) is a probe to expose individual variability in physiological function. Module 2 data will also be used to develop novel statistical and machine learning methods that produce individual and generalizable causal models of nutrition and health.

Module 3 is a controlled feeding study (Intervention arm 2) that is implemented in the live-in/residential setting. A separate subset of Module 1 participants completes the same three diets (Diet A, B, C) as in Module 2, but while residing in a research setting with full supervision of intake, activity, and sleep. The same cohort randomization scheme as in Module 2 determines diet order. The residential environment in Module 3 provides the highest degree of experimental control, allowing isolation of physiological effects of diet composition. Participants undergo a diet-specific meal test (DSMT) as well as a liquid meal test (LMT) accompanied by a dose of acetaminophen after completing each of the diets. In addition, intake balance studies are conducted in this module using the doubly labeled water assessments and DXA for body composition. Data from Module 3 will help quantify and separate variance in the AI/ML models attributable to adherence and other community dwelling factors observed in Module 2 and enables rigorous and controlled comparison against causal relationships discovered in Module 2 data.

In both Modules 2 and 3, participants are masked to the nutritional profile of each diet to minimize expectancy bias. Investigators and diet implementation staff are unmasked.

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (추정된)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
8000

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처

임상 연구를 위한 등록 질문에 답변할 수 있는 사람의 이름과 연락처 정보. 연구가 수행되는 각 위치에는 이러한 질문에 더 잘 대답할 수 있는 특정 연락처가 있을 수 있습니다.

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
        • 모병
        • University of Alabama at Birmingham
        • 수석 연구원:
          • James Hill, PhD
        • 부수사관:
          • Barbara Gower, PhD
        • 연락하다:
          • Sarah Ehrlicher, PhD, RDN
          • 전화번호: 205-934-0027
          • 이메일: nph@uab.edu
    • California
      • Davis, California, 미국, 95616
        • 모병
        • University of California, Davis
        • 부수사관:
          • Francene Steinberg, PhD, RD
        • 부수사관:
          • Alexander Borowsky, MD
        • 수석 연구원:
          • Sean Adams, PhD
        • 연락하다:
      • Davis, California, 미국, 95616
        • 모병
        • USDA Western Human Nutrition Research Center
        • 수석 연구원:
          • Brian Bennett, PhD
        • 연락하다:
      • Los Angeles, California, 미국, 90024
        • 모병
        • University of California, Los Angeles
        • 연락하다:
        • 수석 연구원:
          • Zhaoping Li, MD
      • West Hollywood, California, 미국, 90069
        • 모병
        • Cedars Sinai Medical Center
        • 연락하다:
          • Christina Lombardi, PhD
          • 전화번호: 310-423-1001
          • 이메일: allofus@cshs.org
        • 부수사관:
          • Marc Goodman, PhD
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모병
        • University of Chicago
        • 수석 연구원:
          • Linda Van Horn, Phd, RD, LDN
        • 부수사관:
          • Briseis Aschebrook-Kilfoy, PhD
        • 연락하다:
      • Chicago, Illinois, 미국, 60611
        • 모병
        • Northwestern University
        • 부수사관:
          • Joyce Ho, PhD
        • 부수사관:
          • Marilyn Cornelis, PhD
        • 연락하다:
        • 수석 연구원:
          • Linda Van Horn, PhD, RD, LDN
      • Chicago, Illinois, 미국, 60616
        • 모병
        • Illinois Institute of Technology
        • 부수사관:
          • Britt Burton-Freeman, PhD
        • 연락하다:
          • Illinois Institute of Technology
          • 전화번호: 312-567-5300
          • 이메일: nph-group@iit.edu
        • 수석 연구원:
          • Linda Van Horn, PhD, RD, LDN
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70808
        • 모병
        • Pennington Biomedical Research Center
        • 연락하다:
        • 수석 연구원:
          • Eric Ravussin, PhD
        • 부수사관:
          • Leanne Redman, PhD
      • New Orleans, Louisiana, 미국, 70112
        • 모집하지 않고 적극적으로
        • Louisiana State University Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Sai Das, PhD
        • 부수사관:
          • Hamed Khalili, MD, MPH
        • 연락하다:
      • Boston, Massachusetts, 미국, 02111
        • 모병
        • Tufts University
        • 연락하다:
        • 수석 연구원:
          • Sai Das, PhD
        • 부수사관:
          • Hamed Khalili, MD, MPH
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • 모병
        • University of North Carolina at Chapel Hill - Chapel Hill Clinic
        • 연락하다:
        • 연락하다:
          • 전화번호: 919-808-5686
        • 수석 연구원:
          • Elizabeth Mayer-Davis, Phd, RD
      • Kannapolis, North Carolina, 미국, 28081
        • 모병
        • University of North Carolina at Chapel Hill - Kannapolis
        • 수석 연구원:
          • Elizabeth Mayer-Davis, PhD, RD
        • 연락하다:
        • 연락하다:
          • 전화번호: 704-928-1277

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of >15

    10. History of surgery for the treatment of obesity and:

      1. Self-reported dumping syndrome; or
      2. Following a special diet prescribed by their practitioner

    11. Uncontrolled disease states:

      1. Hypertension >160/100mmHg
      2. Exacerbation of underlying gastrointestinal disease, including inflammatory bowel disease or other malabsorptive disorders
      3. Decompensated cirrhosis
      4. Previously diagnosed diabetes Mellitus with HbA1c >12% at screening
      5. Newly diagnosed diabetes within the past three months, or HbA1c >6.5% at screening in a person not previously diagnosed with diabetes.

    12. Participants with a history of end-stage renal disease (ESRD) on hemodialysis

    13. Active infectious diseases (e.g., active tuberculosis < 3 months from symptom onset or positive test, COVID < 1 month from symptom onset or positive test)

    14. Malignancy (e.g., cancer) actively receiving cytotoxic chemotherapy (oral or infusions) treatment except for nonmelanoma skin cancers during the study period

    15. Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases

    16. Participants with type 1 or type 2 diabetes on insulin

    17. Participants aged ≥ 75 years with type 2 diabetes taking prescribed medications that can cause hypoglycemia (e.g. sulfonylureas, glinides), or on a prescribed diet

    18. Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months

    19. Requiring transfusions/apheresis during study period

    20. Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years

    21. 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

    22. Hemoglobin <9.5 g/dL at screening

    23. Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months

    24. 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.

  • Module 3

    1. All the above mentioned exclusion criteria for Modules 1 and 2

    2. Participants who are already enrolled in Module 2

    3. 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 would interfere with adherence to the protocol

    4. Inability to abstain from tobacco or nicotine use, vaping, alcohol, illicit drug use, or recreational drug use for two (2) consecutive weeks while domiciled in the clinical unit. Nicotine gum, pouch, or patch are permitted.

    5. Any condition requiring in-person treatments or visits during the study period. This will not be accommodated by the domiciling protocol; however, tele-health visits with the participants regular doctor are permitted.

    6. Lactation or other infant care needs that cannot be accommodated while domiciled in the clinical unit

    7. Depression as assessed by:

      1. Patient Health Questionnaire (PHQ-9) score ≥ 15; or
      2. Affirmative answer to PHQ-9 suicidality question: "Thoughts that you would be better off dead or of hurting yourself in some way"

    8. Unable to engage in daily self-care activities (e.g., bathing, transferring, toileting, feeding, dressing)

    9. Uncontrolled endocrine disorders (such as Cushing's disease, pituitary disorders, diabetes)

    10. Uncontrolled pain requiring frequent or daily treatment, or adjustment of medication requiring weekly or bi-weekly visits. Pain medications used on an as-needed basis (PRN), such as acetaminophen or NSAIDs, are not excluded.

    11. Chronic prescription medications that would pose logistical and safety issues for participation

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위화되지 않음
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: 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.
다른: Diet A

This diet has high amounts of fruits/vegetables, whole grains, and beans, moderate amounts of dairy, meat/poultry/eggs, nuts/seeds, and olive oil, and very low amounts of sugar sweetened drinks and desserts.

다른: Diet B

This diet has high amounts of refined grains, meat/poultry/egg, sugar sweetened drinks, snacks, desserts, and processed foods. It has a moderate amount of dairy and low amounts of fruits/vegetables, whole grains, and fish.

다른: Diet C

This diet has moderate-high amounts of vegetables, meat/poultry/egg, nuts/seeds, dairy and fats/oils, low amounts of fruits, and very low amounts of grains and sugars.
실험적: 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.
다른: Diet A

This diet has high amounts of fruits/vegetables, whole grains, and beans, moderate amounts of dairy, meat/poultry/eggs, nuts/seeds, and olive oil, and very low amounts of sugar sweetened drinks and desserts.

다른: Diet B

This diet has high amounts of refined grains, meat/poultry/egg, sugar sweetened drinks, snacks, desserts, and processed foods. It has a moderate amount of dairy and low amounts of fruits/vegetables, whole grains, and fish.

다른: Diet C

This diet has moderate-high amounts of vegetables, meat/poultry/egg, nuts/seeds, dairy and fats/oils, low amounts of fruits, and very low amounts of grains and sugars.

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet A
기간: 4 hours

Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet A.
4 hours
Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet A
기간: 4 hours

Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet A.
4 hours
Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet A
기간: 4 hours

Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet A.
4 hours
GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet A
기간: 4 hours

Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet A.
4 hours
Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet B
기간: 4 hours

Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet B.
4 hours
Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet B
기간: 4 hours

Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet B.
4 hours
Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet B
기간: 4 hours

Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet B.
4 hours
GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet B
기간: 4 hours

Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet B.
4 hours
Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet C
기간: 4 hours

Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet C.
4 hours
Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet C
기간: 4 hours

Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet C.
4 hours
Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet C
기간: 4 hours

Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet C.
4 hours
GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet C
기간: 4 hours

Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet C.
4 hours

2차 결과 측정

2차 결과 측정

임상 연구 프로토콜에서 개입의 효과를 평가하기 위한 1차 결과 측정만큼 중요하지는 않지만 여전히 관심이 있는 계획된 결과 측정입니다. 대부분의 임상 연구에는 하나 이상의 2차 결과 측정이 있습니다.
결과 측정
측정값 설명
기간
Accuracy of energy intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to known intake from objective measures.
기간: 14 days

Agreement will be assessed between total daily energy intake in kilocalories reported via each dietary assessment tool and known intake from the intake-balance method using doubly labelled water and provided diets.
14 days
Accuracy of energy intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.
기간: 14 days

Agreement between energy reported via each dietary assessment tool and measured intake from provided diets, in grams per day.
14 days
Accuracy of carbohydrate intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.
기간: 14 days

Agreement between carbohydrate intake reported via dietary assessment tool and measured intake from provided diets, in grams per day.
14 days
Accuracy of protein intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.
기간: 14 days

Agreement between protein intake reported via each dietary assessment tool and measured intake from provided diets, in grams per day.
14 days
Accuracy of fat intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.
기간: 14 days

Agreement between fat intake reported via each dietary assessment tool and measured intake from provided diets, in grams per day.
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.
기간: 14 days

Agreement between dietary fiber intake reported via each dietary assessment tool and measured intake from provided diets, in grams per day.
14 days
Acceptability scales for ASA24 and Diet A
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for ASA24 and Diet B
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for ASA24 and Diet C
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for mFR and Diet A
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for mFR and Diet B
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for mFR and Diet C
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for AIM-2 and Diet A
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for AIM-2 and Diet B
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for AIM-2 and Diet C
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for ASA24 Record and Diet A
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for ASA24 Record and Diet B
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for ASA24 Record and Diet C
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for mFR+ASA24 and Diet A
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for mFR+ASA24 and Diet B
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days
Acceptability scales for mFR+ASA24 and Diet C
기간: 14 days

Responses to questions on ease of use and tool preference. Principal outcomes will be "ease of use" and "willingness to use again."
14 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
RTI International

협력자

협력자

임상 연구를 지원하는 스폰서 이외의 조직. 이 지원에는 자금 조달, 설계, 구현, 데이터 분석 또는 보고와 관련된 활동이 포함될 수 있습니다.
Boston University
National Cancer Institute (NCI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Massachusetts General Hospital
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
University of California, Los Angeles
Northwestern University
University of Alabama at Birmingham
University of Chicago
Tufts University
Columbia University
Duke University
National Institutes of Health (NIH)
University of Southern California
University of California, Davis
Wake Forest University Health Sciences
Fred Hutchinson Cancer Center
Vanderbilt University Medical Center
National Center for Complementary and Integrative Health (NCCIH)
University of North Carolina, Chapel Hill
USDA, Western Human Nutrition Research Center
Cedars-Sinai Medical Center
Pennington Biomedical Research Center
Virginia Commonwealth University
Indiana University
Louisiana State University Health Sciences Center in New Orleans
University of Alabama, Tuscaloosa
University of Hawaii
National Center for Advancing Translational Sciences (NCATS)
Cornell University
Purdue University
Verily Life Sciences LLC
National Institute of Drug Abuse
North Carolina State University
University of North Carolina, Charlotte
Illinois Institute of Technology
City University of New York, School of Public Health
North Carolina Central University
Stevens Institute of Technology
Public Health Informatics Computational and Operations Research
Children's Hospital of Richmond
United States Military Academy West Point

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 수석 연구원: Marie G Gantz, PhD, RTI International

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2023년 4월 14일

기본 완료 (추정된)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 2월 25일

연구 완료 (추정된)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 2월 25일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2023년 1월 11일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2023년 1월 26일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2023년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 10월 13일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 10월 7일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • Pro00062970
  • UG1HD107692 (미국 NIH 보조금/계약)
  • U24HD107676 (미국 NIH 보조금/계약)
  • UG1HD107691 (미국 NIH 보조금/계약)
  • UG1HD107697 (미국 NIH 보조금/계약)
  • UG1HD107688 (미국 NIH 보조금/계약)
  • UG1HD107696 (미국 NIH 보조금/계약)
  • UG1HD107711 (미국 NIH 보조금/계약)
  • U54TR004279 (미국 NIH 보조금/계약)
  • U24CA268153 (미국 NIH 보조금/계약)
  • U24DK131617 (미국 NIH 보조금/계약)
  • U24CA268228 (미국 NIH 보조금/계약)
  • U24OD023121 (미국 NIH 보조금/계약)
  • OT2OD035404 (미국 NIH 보조금/계약)
  • AOD22022001 (기타 보조금/기금 번호: National Institutes of Health (NIH) Inter Agency Agreement)
  • OT2OD030043 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

IPD and related data dictionaries will be available in the All of Us Researcher Workbench.

IPD 공유 기간

One year after study completion

IPD 공유 액세스 기준

Per the policies of the All of Us Research Workbench

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

쿠키 설정

당사는 당사 웹 사이트에서 최상의 경험을 제공하기 위해 쿠키를 사용합니다. 자세한 내용은 개인 정보 보호 및 쿠키 정책 을주의 깊게 읽어보십시오. ...>>>귀하는 정책에 설명 된대로 귀하의 웹 사이트 또는 컴퓨터에서 쿠키를 삭제하여 언제든지 귀하의 기본 설정을 변경하거나 동의를 철회 할 수 있습니다. 동의하고 아래 "설정 관리"섹션에서 해당 상자를 선택하여 기본 설정을 선택하십시오. 이 웹 사이트의 일부를 사용하기 전에 서비스 약관 을주의 깊게 읽어 보시기 바랍니다.
«설정 관리