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Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data

Discovering Determinants of Food Intake by Application of Machine Learning to Complex, High-Dimensional Data

Background:

Many people in the United States are overweight or obese. Researchers want to learn why some people can overeat and not gain weight, whereas others who do not overeat still gain weight.

Objective:

To study factors related to food intake that can lead to weight gain over time.

Eligibility:

Healthy adults aged 18 to 60 years.

Design:

Participants will have 6 to 8 clinic visits over 2 years. The first 3 or 4 study visits will be 1 week apart.

Procedures during visits may include the following:

Collection of blood, hair, urine, and stool samples.

Measurement of the waist, neck, thighs, and other parts of the body.

Dual energy x-ray absorption (DXA) scan: Participants will lie still on a padded table while they are scanned to measure body fat.

Physical activity monitor: Participants will wear a monitor on the wrist for 2 weeks.

Cognitive tests: Participants will perform tasks to measure attention, memory, and brain function.

Continuous glucose monitor. Participants will wear a device that measures their blood glucose for 1 week.

Mixed meal test and stomach emptying test. Participants will drink a breakfast shake and swallow a dose of acetaminophen. Blood will be drawn over the next 4 hours.

Resting metabolic rate: Participants will wear a clear hood over their head while they rest for 20 minutes. The hood will measure the gases they breathe.

Breakfast and lunch test. Participants will eat a standard breakfast. They will be allowed to select from foods and eat as much as they like at lunch. They will be asked how hungry or full they are.

Questionnaires. Participants will answer questions about their health, sleep, physical activity, and eating.

연구 개요

상태

아직 모집하지 않음

상세 설명

Study Description:

The study will be an outpatient study with 6-7 total visits, 3-4 completed at baseline and 3 follow-up visits, occurring over 2 years. We will collect broad, multiscale data (e.g., clinical, genetic, microbiome, energy expenditure, physical activity, psychosocial). Then, we will apply artificial intelligence algorithms with the goal of identifying novel determinants of food intake.

Objectives:

Primary Objective:

To identify novel determinants of objectively measured ad libitum energy intake using broad, multiscale data.

Secondary Objectives:

  1. To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolic health.
  2. To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
  3. To identify novel determinants of ad libitum self-reported energy and nutrient intake

Endpoints:

Primary Endpoint: Energy intake during ad libitum meal test, including total energy and macronutrient specific energy intake (e.g., carbohydrate, fat, protein) measured during the initial baseline period (visit 3). The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.

Secondary Endpoints:

  1. Measures at 0.5, 1, and 2 years of body weight, BMI, fat mass, body fat percentage, HbA1c, and fasting glucose, lipids, insulin, and c-peptide.
  2. Psychosocial measures (visits 1-6), metabolic measures (e.g., fasting glucose, HbA1c, lipids, insulin, and c-peptide), resting metabolic rate, total energy expenditure, and physical activity
  3. Energy and nutrient intake from ASA-24. The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.

연구 유형

관찰

등록 (추정된)

800

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

    • Arizona
      • Phoenix, Arizona, 미국, 85004
        • NIDDK, Phoenix, 850 N. 5th Street 7th Floor
        • 연락하다:

참여기준

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

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

800 males and females, age 18-60 years who are in good health

설명

  • INCLUSION CRITERIA

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Age 18 to 60
  3. In good general health as evidenced by medical history and physical exam

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Weight >=204 kg (>=450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight <45.4 kg (<100 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)
  2. Unstable weight (+/-5%) within past 6 months as determined by volunteer self-report.
  3. Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism
  4. Inability to consume provided food based on food allergy or intolerance or other food restrictions (e.g., kosher, vegan, or vegetarian)
  5. Current pregnancy, or recent pregnancy within past 6 months or currently lactating
  6. History or clinical manifestation of:

6i. Diabetes, including fasting glucose >= 126 mg/dl or HbA1c >= 6.5%, or history

6ii. Surgery for treatment of obesity

6iii. Endocrine disorders, such as Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism (TSH <0.1 or >= 10 uIU/mL)

6iv. Pulmonary disorders including chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol

6v. History of coronary artery disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol

6vi. Liver disease, including cirrhosis, active hepatitis B or C based on history, and AST or ALT >= 3x normal

6vii. Gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, or other malabsorptive disorders by history

6viii. Hematologic disorders including significant anemia (male hemoglobin < 13.0 g/dL or female hemoglobin < 11.0 g/dL)

6ix. Renal disease including abnormal kidney function (eGFR <60 mL/min/1.73m^2)Subjects page 4, Eligibility Criteria

6x. Central nervous system disease, including cerebrovascular accidents, dementia, and neurodegenerative disorders by history

6xi. Cancer requiring treatment in the past 5 years, except for nonmelanoma skin cancers or cancers that have clearly been cured

6xii. Infectious disease such as active tuberculosis, HIV (by self-report), chronic coccidiomycosis or other chronic infections that might influence appetite

6xiii. Diagnosis of binge eating disorder, anorexia, or major psychiatric disorders including depression, schizophrenia, and psychosis

6xiv. Menopausal transition (late) to early postmenopause (e.g., >= 2 skipped cycles and an interval of amenorrhea >= 60 days and <12 months)

7. Alcohol abuse as defined by >= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire interview

8. Inability to provide informed consent

9. Any disorder, unwillingness, or inability not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators, such as those that jeopardize the safety of the participant or others, or would interfere with completion of study procedures

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
1
800 males and females, age 18-60 years who are in good health

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To identify novel determinants of objectively measured ad libitum energy intake using broad, multiscale data.
기간: 24-28 months
Energy intake during ad libitum meal test, including total energy and macronutrient specific energy intake (e.g., carbohydrate, fat, protein) measured during the initial baseline period (visit 3). The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.
24-28 months

2차 결과 측정

결과 측정
측정값 설명
기간
To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolichealth
기간: 24-48 months
Measures at 0.5, 1, and 2 years of body weight, BMI, fat mass,body fat percentage, HbA1c, and fasting glucose, lipids, insulin,and c-peptide.
24-48 months
To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
기간: 24-48 months
Psychosocial measures (visits 1-6), metabolic measures (e.g., fasting glucose, HbA1c, lipids, insulin, and c-peptide), resting metabolic rate, total energy expenditure, and physical activity
24-48 months
To identify novel determinants of ad libitum self-reported energy and nutrient intake
기간: 24-28 months
Energy and nutrient intake from ASA-24. The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3
24-28 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Susanne M Votruba, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

간행물 및 유용한 링크

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

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 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2037년 7월 1일

연구 완료 (추정된)

2037년 7월 1일

연구 등록 날짜

최초 제출

2026년 6월 9일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 5일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 10001858
  • 001858-DK

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

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. .

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