NCT06690294Not yet recruiting
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism: A Natural History Study
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 13 Nov 2024
- Start date
- 10 Nov 2026
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Diseases
- Obesity
- NCT number
- NCT06690294
What you commit to
- Study type: Observational
- Planned participants: 110
- From 10 Nov 2026 to the primary completion date, 30 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Central nervous system disease:
- --Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism.
Other illness
- Endocrine disorders, such as
- --Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism
- 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)
- Gastrointestinal Surgery
- --Self-reported history of bariatric surgery
- Infectious disease:
- --Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections
- Self-reported history of psychological conditions including (but not limited to), active psychosis, schizophrenia, eating disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.
- Inability to consume provided food during ad libitum food intake or snack food test based on a food allergy or intolerances or diet restrictions.
- Any disorder not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.
- Alcohol Abuse as defined by \>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire will be an exclusion criterion.
Lab values
- Diabetes
- Fasting glucose \>= 126 mg/dl or HbA1c \>= 6.5% or
- Self-reported history of type 1 or type 2 diabetes.
- 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
- 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)
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- TSH \<=0.27 or \>= 10 uIU/mL
- 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)
- Inability to provide informed consent.
- Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) will be an exclusion criterion.
- Non-English-speaking subjects as a population will be excluded from participation in this protocol. Primary and secondary hypotheses of the protocol relate to a battery of psychological questionnaires and performances tests which are administered throughout the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.
Criteria the registry did not label
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- 18-60 years of age.
- Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIDDK, Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.