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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01694056
Eligibility Criteria:
Inclusion Criteria:
* Women
* 45-70 years
* No menstrual cycle for ≥1 year
* Stable body weight for ≥6 months (no weight gain/loss \> 3 kg)
* Stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
* Central obesity: waist circumference ≥80 cm
Plus any one of the following four factors:
* Raised triglyceride level: ≥1.7 mmol/L;
* Reduced high-density lipoprotein (HDL) cholesterol: \<1.29 mmol/L
* Raised blood pressure: systolic blood pressure ≥135 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication
* Raised fasting plasma glucose ≥ 5.6 mmol/L
Exclusion Criteria:
* (Undiagnosed) Diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening
* Active hearth disease, i.e. history of myocardial infarction, stroke or angina pectoris
* Active or a history of thyroid disease
* Cancer or other malignancies in the past 5 years
* Two sided ovariectomy
* Drug use knowing to interfere with objectives of the study
* oral corticosteroids, lipid-lowering drugs (statins)
* anti-conceptive use (such as the pill or IUD)
* hormone replacement therapy
* long-term antibiotics use
* Habitual intake of soy foods (\>1 soy food per week)
* Isoflavone supplements
* Vegetarian
* Following, or have recently followed a (weight-loss) diet
* Allergic to soy or dairy products
* Smoking
* Consuming more than 14 glasses of alcohol per week
* Donated or intended to donate blood 2 months before till two months after the study
* Participation in another biomedical study within 1 month before the first screening visit
* Not willing to be informed if deviations are found in blood samples
* Contraindications to MRI scanning
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT01694056
Study Brief:
Protocol Section:
NCT01694056