Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06690294
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
* Random glucose \>= 200 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 selfreport) 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.
* Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2).
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06690294
Study Brief:
Protocol Section:
NCT06690294