Healthy VolunteerNCT07637656
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
An observational study of Healthy Volunteer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy Volunteer
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 1 Jul 2037
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 800 males and females, age 18-60 years who are in good health
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
NIDDK, Phoenix
Phoenix, Arizona, 85014
Douglas Chang, M.D., 602-200-5312, douglas.chang2@nih.gov
About this study
Official title: 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.
Read more
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.
Read the detailed description
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:
- To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolic health.
- To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
- 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:
- 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.
- 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
- Energy and nutrient intake from ASA-24. The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.
- Conditions
- Healthy Volunteer
- Keywords
- Food Intake, Energy Expenditure, Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 800 males and females, age 18-60 years who are in good health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-28 months
Secondary outcomes (3)
To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolichealth
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.
Measured: 24-48 months
To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
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
Measured: 24-48 months
To identify novel determinants of ad libitum self-reported energy and nutrient intake
Energy and nutrient intake from ASA-24. The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3
Measured: 24-28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start28 Oct 2026 (estimated)
- Primary completion1 Jul 2037 (estimated)
- Study completion1 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susanne M Votruba, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637656
- Sponsor's protocol ID
- 10001858
- Other IDs
- 001858-DK
- Status last verified
- 26 Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided