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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00963118
Eligibility Criteria:
Inclusion Criteria: healthy control group (n=20)
1. Age: over 50 years old
2. Female subjects must be post-menopausal
3. BMI: 18.5 - 30, waist/hip ratio \< 0.9 for men, \< 0.85 for women
4. TG\<150 mg/dL (1.7 mmol/L) and no medication for TG
5. Total cholesterol \< 200 mg /dL (5.18 mmol/L) and no medication for cholesterol
6. Blood pressure: SBP \< 130 mmHg and DBP \< 85 mmHg and no hypertensive medication
7. Plasma glucose: fasting blood glucose \< 100 mg/dL (5.6 mmol/L) and no diabetes medication
Inclusion Criteria: Metabolic syndrome (n=40)
1. Age: over 50 years old
2. BMI: \> 30 or waist/hip ratio \> 0.9 for men, \> 0.85 for women
3. Plus any two of the following four factors:
* TG: 150-400 mg/dL (1.7 - 4.52 mmol/L) and/or medication for TG
* HDL cholesterol: \<40 mg /dL (1.03 mmol/L) for men, \<50 mg/dL (1.29 mmol/L) for women and/or medication for cholesterol
* Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg and/or antihypertensive medication
* Plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no diabetes medication
Exclusion Criteria:
1. Study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption.
2. Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders will be excluded from the study.
3. Exogenous hormone users will be excluded from the study.
4. Moreover, subjects will be non-smokers and will not have taken vitamin or carotenoid supplements for at least 6 weeks prior to the study and throughout the study for both healthy subjects and subjects with metabolic syndrome.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00963118
Study Brief:
Protocol Section:
NCT00963118