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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01127867
Eligibility Criteria:
Inclusion Criteria:
Post-menopausal defined as:
1. 24 consecutive months without a menstrual period AND
2. low serum estradiol level (\<40 ng/ml) to be assessed at screening AND
3. not taking any medication known to induce ammenorrhea AND
4. no known endocrine abnormality associated with irregular/absent menses.
5. BMI 35-50.
Exclusion Criteria:
1. Currently taking any hormone therapy: oral, transplanted, vaginal, injected
2. Currently taking NSAIDS (if \> once a week, stopped \< 30 days ago)
3. Currently taking oral hypoglycemics
4. Currently taking anticoagulant mediation or stopped \< 30 days ago
5. History of any malignancy or cancer treatment in the past 3 years
6. Blood Pressure \> 150/90 at screening
7. History of any bleeding disorder
8. Screening LFT results \> 2x normal upper limits
9. Screening renal lab results \> 2x normal upper limits
10. Any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could complicate the study results, or may interfere significantly with participation in the study.
11. History of intestinal malabsorption
12. Screening urinalysis positive for blood
13. History of chronic diarrhea
14. History positive for HIV
15. Currently on any medication that can alter fat stores or large bowel inflammation as deemed by the principal investigator
16. History of inflammatory bowel disease
17. Screening thyroid function test abnormal
18. Currently taking any weight control medication
19. HIV positive as per POCT rapid test at screening
20. Currently taking fish oil, omega-3 supplements or other herbals that exceed the GRAS (Generally Recognized As Safe) levels
21. Fasting blood sugar greater than 126 mg/dL at screening
22. Currently taking more than 3 antihypertensive medications
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01127867
Study Brief:
Protocol Section:
NCT01127867