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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01593605
Eligibility Criteria:
Inclusion Criteria:
* Impaired fasting glucose as defined by American Diabetes Association criteria: fasting plasma glucose level from 5.6 mmol/L (100 mg/dL) to 6.9 mmol/L (125 mg/dL)
* Body mass index (BMI) 25-34.9
* Age 18 and above• Weight stable: no more than 1 kg weight gain or loss during past 12 weeks
Exclusion Criteria:
* Fasting glucose \>126 or \<99 mg/dL
* BMI \< 25 or \>35
* Current/previous diagnosis of diabetes
* History of eating disorder or presence of active gastrointestinal disorders such as malabsorption syndromes
* Pregnancy or lactation Anemia, defined as hemoglobin level less than 10g/dl.
* Use of obesity pharmacotherapeutic agents within the last 6 months
* Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropylamine , ephedrine and/or caffeine) within the last 3 months
* Chronic use of anti-inflammatory agents within the last four weeks
* Use of antioxidant supplements within the last four weeks including selenium, vitamin E, vitamin C and/or carotenoids
* Use of supplements containing any of the study compounds within the past four weeks
* Recent (current or past 12 weeks) use of any psychotropic medication
* Recent (past four weeks) initiation of or change in an exercise program
* Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
* Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
* Recent (past 12-weeks) history of tobacco use
* Any Condition that the P.I. considers adverse to the participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01593605
Study Brief:
Protocol Section:
NCT01593605