Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
2 other identifiers
observational
800
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedStudy Start
First participant enrolled
June 17, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2037
Study Completion
Last participant's last visit for all outcomes
July 1, 2037
June 12, 2026
June 8, 2026
11 years
June 9, 2026
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To identify novel determinants of objectively measured ad libitum energy intake using broad, multiscale data.
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
Secondary Outcomes (3)
To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolichealth
24-48 months
To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
24-48 months
To identify novel determinants of ad libitum self-reported energy and nutrient intake
24-28 months
Study Arms (1)
1
800 males and females, age 18-60 years who are in good health
Eligibility Criteria
800 males and females, age 18-60 years who are in good health
You may qualify if:
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 to 60
- In good general health as evidenced by medical history and physical exam
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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)
- Unstable weight (+/-5%) within past 6 months as determined by volunteer self-report.
- Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism
- Inability to consume provided food based on food allergy or intolerance or other food restrictions (e.g., kosher, vegan, or vegetarian)
- Current pregnancy, or recent pregnancy within past 6 months or currently lactating
- History or clinical manifestation of:
- i. Diabetes, including fasting glucose \>= 126 mg/dl or HbA1c \>= 6.5%, or history
- ii. Surgery for treatment of obesity
- iii. Endocrine disorders, such as Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism (TSH \<0.1 or \>= 10 uIU/mL)
- iv. Pulmonary disorders including chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol
- v. History of coronary artery disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol
- vi. Liver disease, including cirrhosis, active hepatitis B or C based on history, and AST or ALT \>= 3x normal
- vii. Gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, or other malabsorptive disorders by history
- viii. Hematologic disorders including significant anemia (male hemoglobin \< 13.0 g/dL or female hemoglobin \< 11.0 g/dL)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIDDK, Phoenix
Phoenix, Arizona, 85014, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne M Votruba, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2026
First Posted
June 10, 2026
Study Start (Estimated)
June 17, 2026
Primary Completion (Estimated)
July 1, 2037
Study Completion (Estimated)
July 1, 2037
Last Updated
June 12, 2026
Record last verified: 2026-06-08