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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01698112
Eligibility Criteria:
Inclusion Criteria:
* (1) no unresolved health conditions (e.g. if high blood pressure is present it is under control due to diet and/or medications) and no diagnosis of type 2 diabetes;
* (2) non-smoking status;
* (3) no regular history of flaxseed or flaxseed oil supplement or fish oil supplement intake;
* (4) no regular history of sunflower seed intake (1/8 cup \< 1 time per week); fish intake (\< 12 ounces of fish/week); and soy intake (1 serving of soy \< 3 times per week; 1 serving of soy equals 3 oz. tofu, 8 oz. soy milk, ¼ c. soy nuts or ½ c. edamame);
* (5) willingness to follow study protocol, scheduling, and testing location;
* (6) body mass index (BMI) of 25-34.9 kg/m2;
* (7) men or postmenopausal women (no menstrual cycle for \> 6 months; women who have had a hysterectomy are eligible for participation) ages 50-65 years;
* (8) fasting glucose value of \> 100 and \< 126 mg/dL.
Exclusion Criteria:
* (1) unresolved health conditions or diagnosis of type 2 diabetes;
* (2) smokes;
* (3) regular history of flaxseed or flaxseed oil supplement or fish oil supplement intake;
* (4) regular history of sunflower seed intake (1/8 cup \< 1 time per week); fish intake (\< 12 ounces of fish/week); and soy intake (1 serving of soy \< 3 times per week; 1 serving of soy equals 3 oz. tofu, 8 oz. soy milk, ¼ c. soy nuts or ½ c. edamame);
* (5) unwillingness to follow study protocol, scheduling, and testing location;
* (6) body mass index (BMI) less than 25 or greater than 34.9 kg/m2;
* (7) premenopausal women;
* (8) men or postmenopausal women less than 50 or greater than 65 years of age;
* (9) fasting glucose value of less than 100 or greater than 126 mg/dL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT01698112
Study Brief:
Protocol Section:
NCT01698112