About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
800 males and females, age 18-60 years who are in good health
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: