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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00866151
Eligibility Criteria:
Inclusion Criteria:
* BMI (body mass index): 27-40 kg/m2
* Gender: Women only
* Age: 25-50
* Menopausal status: pre-menopausal
* Weight stable for last 2-months
* Not on a weight loss plan
* No ethnic restrictions
* No plans to move from the area over the next 6-months
* Willing to accept random assignment
* Possess English speaking and reading skills to understand and complete forms such as informed consent and study evaluation
Exclusion Criteria:
* Hypertension
* Diabetes (type 1 or 2) or history of gestational diabetes
* Heart disease diagnosis
* Renal or lever disease
* Active neoplasms
* Pregnant, lactating, within 6-months of birth, or planning to become pregnant in the next 6-months
* Hyperthyroidism, unless treated and under control
* Medications known to affect weight / energy expenditure
* Excessive alcohol intake (self-reported, \> 3 drinks/day)
* Postmenopausal, including surgical menopause
* Currently under psychiatric care, or severely clinically depressed (\>17 on Beck Inventory)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT00866151
Study Brief:
Protocol Section:
NCT00866151