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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00654667
Eligibility Criteria:
Inclusion Criteria:
1. Adults ages 50 years or older
2. Women ages 50 years and older who are postmenopausal, defined as no menses for the previous 12 months
3. BMI 25 to 35
4. Waist-to-hip circumference ratios for men \>0.95, for women \>0.85
5. HOMA-IR score from fasting plasma glucose and serum insulin levels \>2.7
6. A diet consisting of \> 40% calories from fat; and
7. Sedentary, defined as no formal exercise program and less than 30 minutes physical activity weekly.
Exclusion Criteria:
1. Active malignancy or tumor or other condition that would severely limit life expectancy
2. Any type of major surgery during the last 3 months
3. Psychiatric disorders with currently active manifestations
4. Insulin-dependent diabetes
5. Any chronic medications except for hormone replacement therapy. Vitamin supplements (of any type) are not allowed during the study, but are acceptable if the participant agrees to a 2 week washout period before participation in the study
6. Active symptoms suggestive of an acute coronary syndrome or decompensated heart failure
7. Currently on low fat diet or special diet (i.e. weight loss)
8. Excessive alcohol intake (\>3 glasses of wine/1 six pack of beer daily)
9. Concurrent participation in any drug studies or studies that require sample of a body fluid (or having finished in the past 6 months)
10. Non-English speakers
11. Abnormal LFTs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00654667
Study Brief:
Protocol Section:
NCT00654667