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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01350518
Eligibility Criteria:
Inclusion Criteria:
* Pre-menopausal
* Self-identified as an African-American woman
* Aged 20-50 years
* Willing and able to provide informed consent
* No contraindication to weight loss
Exclusion Criteria:
* Diabetes or currently taking medication to lower blood sugar
* Currently on lipid lowering medications
* Currently taking chronic steroids
* Current diagnosis of kidney or heart failure
* Untreated hypothyroidism or hyperthyroidism
* BMI \< 30 kg/m2 or waist circumference \< 88 cm
* Current fiber supplementation
* Current pregnancy
* Body mass \> 140 kg (CT limit)
* Inability to speak or read English
* Gastrointestinal disorders that prohibit the increased consumption of fiber
* Current participation in a structured weight loss/diet intervention program
* Inability to consume artificial sweeteners
* Inability or unwillingness to travel to the CRU during operating hours at the required frequency.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01350518
Study Brief:
Protocol Section:
NCT01350518