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:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT02939404
Eligibility Criteria:
* INCLUSION CRITERIA:
* Premenopausal women and men \<55 years of age
* Body weight \<204 kg (\<450 pounds) and \>= 36 kg (\>= 80 pounds)
* Stable weight (+/-5% within past 6 months) as determined by volunteer report
* Healthy, as determined by medical history, physical examination, and laboratory tests
EXCLUSION CRITERIA:
* Age \<18 years
* Weight greater than or equal to 204 kg (greater than or equal to 450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight \<36 kg (\<80 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)
* Use of medications affecting metabolism and appetite in the last three months
* Expresses unwillingness to consume all food given during the weight maintaining diet portions of the study (e.g., due to strict dietary restrictions including allergies or vegetarian or kosher diet)
* Current use of tobacco products, marijuana, amphetamines, cocaine, or intravenous drug use
* Current pregnancy, pregnancy within the past 6 months or lactation
* History or clinical manifestation of:
* Type 1 and Type 2 diabetes mellitus
* History of surgery for the treatment of obesity
* Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo and hyperthyroidism
* Pulmonary disorders, including chronic obstructive pulmonary disease
* Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
* High blood pressure by sitting blood pressure measurement using an appropriate cuff higher than 140/90 mmHg on two or more occasions, or current antihypertensive therapy
* Liver disease, including cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 2x normal
* Gastrointestinal disease including Crohn s disease, ulcerative colitis, celiac disease or other malabsorptive disorders
* Abnormal kidney function (eGFR \<60 mL/min/1.73m(2))
* Central nervous system disease, including previous history of cerebrovascular accidents, dementia, neurodegenerative disorders or history of severe head trauma
* Cancer requiring treatment in the past five years, except for nonmelanoma skin cancers or cancers that have clearly been cured
* Infectious disease such as active tuberculosis, HIV (by self report), chronic coccidiomycoses or other chronic infections that might influence EE and weight
* Diagnosis of binge eating disorder, anorexia and major psychiatric disorders based upon the DSM-IV including depression, schizophrenia and psychosis, which may impact the ability of the participant to be in the respiratory chamber for 24 hour time periods
* Chronic ethanol use (more than 3 drinks/day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02939404
Study Brief:
Protocol Section:
NCT02939404