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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02627105
Eligibility Criteria:
Inclusion Criteria:
1. Males and females between 18 - 50 years old
2. BMI of 27 or greater
3. Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
4. Generally healthy
5. Able to exercise 70 minutes per day at moderate intensity
6. Willing and able to participate in a weekly group class for the first 16 weeks of the study and willing to participate in 4 study visits over the 6 month study period
Exclusion Criteria:
1. Pregnant or trying to become pregnant.
2. Diagnosis of type 1 or type 2 diabetes
3. Individuals following a vegetarian/vegan only diet
4. Food allergies (to red meats or other common protein sources)
5. Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals which do not have a weight effect are allowed as long as use is continued without change during the study.
6. Current Eating disorder (anorexia or bulimia)
7. Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
8. Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable
9. LDL cholesterol levels above 160 mg/dl or triglycerides above 400 mg/dl.
10. Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02627105
Study Brief:
Protocol Section:
NCT02627105