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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT02703766
Eligibility Criteria:
Inclusion Criteria
* Age: 18 to 40 (inclusive) years
* BMI 18.5 \<30 kg/m2
* Gender: Both males and females will be allowed to participate in the study
* Predominantly sedentary
* Absence of any chronic medical conditions other than seasonal or environmental allergies
* On no prescription medications other than second generation antihistamines (cetirizine , Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices
* Not a current smoker or tobacco user
* Not pregnant or breast feeding and not intending to become pregnant or breast feed
* Lean (low body fat mass) (body fat content ≤ 25% for men, \< 35% for women) n=7; Obese (high body fat mass) (body fat content \>25% for men, ≥ 35% for women) n=7
* Ability to provide written informed consent
Exclusion Criteria
* Vulnerable study population will be excluded
* Presence of chronic diseases such as diabetes, and cardiovascular disease
* Pregnancy
* Anemic (hemoglobin \<13.5 g/dL for men and \<12.0 g/dL for women)
* Postmenopausal
* Smoking
* Use of chronic Medications (aspirin, statin, anti-inflammatory drugs)
* Subjects found to have significant sleep disorders will be excluded
* Dietary restrictions including lactose intolerance, and vegan diet
* Eating disorders that may interfere with weight gain and weight loss
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02703766
Study Brief:
Protocol Section:
NCT02703766