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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01516333
Eligibility Criteria:
Inclusion Criteria:
* Body Mass index between 25-35 kg/m2
* Fasting serum glucose
* Fasting serum glucose \< 125 mg/dl
* Free of chronic disease
* Willing to eat only the foods that are provided by the Center during the diet periods
* Willing to abstain from the consumption of alcohol during the diet periods
* Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
* Monophasic birth control (same dose each day)
* Hormone replacement therapy
* Post-menopausal (over 1 year without bleeding)
* Have had partial hysterectomy over the age of 55
* complete hysterectomy at any age
Exclusion Criteria:
* Documented presence of atherosclerotic disease
* Diabetes mellitus
* Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
* Body Mass Index \<25 or \> 35
* History of drug or alcohol abuse in the last year
* For women, pregnancy, breast feeding or postpartum \< 6 months
* History of depression or mental illness requiring treatment or medication within that last 6 months
* Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
* Lifestyle or schedule incompatible with the study protocol
* Planned continued use of dietary supplements through the study trial
* Smoking or tobacco use
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01516333
Study Brief:
Protocol Section:
NCT01516333