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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT02774668
Eligibility Criteria:
Inclusion Criteria:
1. Men and premenopausal women
2. 30-55 years of age
3. Sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day
4. Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study)
5. Overweight/obese subjects with BMI 27.0 - 40.0 kg/m2 and any one of the following characteristics of the metabolic syndrome:
A. Serum HDL cholesterol \<40 mg/dL (1 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women B. Blood pressure ≥130/85 mmHg C. Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) D. Waist circumference in men of \>102 cm (40 in) and in women of \>88 cm (35 in) E. Serum triglycerides (TG) ≥150 mg/dL (1.7 mmol/L).
Exclusion Criteria:
1. Abnormal thyroid function or known liver disease
2. Diabetes or fasting glucose ≥ 125 mg/dL
3. Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules)
4. Occasional or regular tobacco use
5. History of gout
6. Uncontrolled hypertension
7. Pregnant or peri-menopausal
8. Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy)
9. Alcohol intake: females \> 70 g/wk, males \>140 g/wk
10. Moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT02774668
Study Brief:
Protocol Section:
NCT02774668