Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Starting soon
Conditions studied: Healthy Volunteer, Obestity
In brief
Background: Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults. Objective: To explore how childhood experiences affect adult eating behaviors. Eligibility: Healthy people aged 18 to 60 years. Design: Participants will have 3 clinic visits. They will be screened with blood tests. They will answer questions about their alcohol and tobacco use. At the next visit, participants will undergo these activities: Parts of their body (such as waist, neck, and thighs) will be measured with a tape. They will have an imaging scan to find out how much body fat they have. They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days. They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days. They will answer questions about their education, childhood, and routines. They will receive a kit to collect a stool sample at home. At the last visit, participants will have these tests: Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head. Blood samples will be taken before and after participants drink a sugary drink. Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.
Key facts
- Study ID
- NCT06690294
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 110
- Starts
- 2026-08-12
- Expected to finish
- 2027-01-30
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diabetes
- Fasting glucose >= 126 mg/dl or HbA1c >= 6.5% or
- Self-reported history of type 1 or type 2 diabetes.
- Endocrine disorders, such as
- -Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism
- TSH <0.1 or >= 10 uIU/mL
- Pulmonary disorders
- -Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)
- Cardiovascular diseases,
- -Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)
- Liver disease,
- Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)
- AST or ALT elevations > 3 times upper limit of normal
- Gastrointestinal Surgery
- -Self-reported history of bariatric surgery
- Renal disease
- Self-reported history of renal replacement therapy
- Abnormal kidney function (defined as eGFR <60 mL/min/1.73m\^2) determined at screening (eGFR values are computed using the 2021 CKD-epi equation)
- Central nervous system disease:
- -Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Infectious disease:
- -Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections
- For Females: pregnancy, <=6 months postpartum, currently breastfeeding, or on birth control (i.e., ingested, injected or implanted; non-hormonal methods such as copper IUD will be allowed)
- Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)
Where it is running
- NIDDK, Phoenix — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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