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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01622634
Eligibility Criteria:
Inclusion Criteria:
* Women aged 30-65 yrs of age, inclusive
* Waist circumference \> 88 cm.
* Weight stable (within 2 kg) for past 6 mo
* Sedentary/Low-active (defined as \<300minutes/wk light or moderate activity, with no vigorous activity in last 6 months)
* At risk for MetS \[defined as having 2 of the following 4 factors: 1) hypertriglyceridemia defined as \> 150 mg/mL, 2) low HDL cholesterol defined \< 50 or on medication, 3) elevated blood pressure defined as \> 130/\>85 Hg or taking medications or 4) hyperglycemia defined as fasting blood glucose \> 100 or glycated hemoglobin \> 6.5 or taking medications.
* Willing to be randomized to the four treatment groups
Exclusion Criteria:
* Any chronic disease/condition that would not permit exercise or dietary restriction (including egg allergy or refusal to incorporate eggs into the diet) or alter interpretation of data. Examples include, but are not limited to:
1. cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease; 2) severe orthopedic, musculoskeletal or neuromuscular impairments that would contradict exercise; 3) sensory impairments that interfere with following directions; 4) diagnosis of dementia; 5) history of malignancy during the past 5 yr; 6) medication use that impacts primary outcomes of interest (e.g. statins); 7) weight greater than 400 pounds due to DXA weight and size limitations; 8) Uncontrolled blood pressure defined as \> 160/\>100 Hg.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01622634
Study Brief:
Protocol Section:
NCT01622634