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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 60 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 3 visits
- Time periods mentioned: 10 days
- Procedures mentioned: Blood draws, Wearing a device, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Design: Participants will have 3 clinic visits."
- "They will be screened with blood tests."
- "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."
- "Blood samples will be taken before and after participants drink a sugary drink."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how childhood experiences may affect eating habits and weight gain in adults. It is for healthy people ages 18 to 60 and includes 3 clinic visits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 60 years old.
- Be willing to follow all study steps and be available for the whole study.
- Be able to read and understand English well enough to complete study surveys.
Who can't join
- Have diabetes, certain hormone disorders, or thyroid blood test results outside the study's limits.
- Have lung, heart, or advanced liver disease that limits study participation; high liver blood test results; poor kidney function; or a history of dialysis or other kidney replacement treatment.
- Have had weight-loss surgery, a stroke, dementia, or a disease that damages the brain or nerves; or have an infection such as active tuberculosis or HIV.
- Be pregnant, have given birth within the past 6 months, be breastfeeding, or use birth control taken by mouth, injected, or implanted. Non-hormonal methods, such as a copper IUD, are allowed.
- Weigh 450 pounds or more, or be unable to eat the study foods because of allergies, food intolerance, or diet limits.
- Be unable to give informed consent, meaning you understand and agree to join; have a mental health condition that makes participation unsafe; or have another condition the study team thinks makes participation unsafe or difficult.
- Use medicines, supplements, or other treatments known to change how the body uses energy.
- Score 8 or higher on the study's alcohol-use survey, or currently use tobacco and score above 2 on its nicotine-dependence test.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* 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). EXCLUSION CRITERIA: 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 \<=0.27 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) * Inability to provide informed consent. * 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. * Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism. * 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. * 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.
Study sites (1)
AZ
- NIDDK, Phoenix · Phoenix, AZ 85014More trials in Phoenix