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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02376660
Eligibility Criteria:
Inclusion Criteria:
* Men and women between 20 and 50 years old
* Total Cholesterol: ≥ 200 mg/dL and \< 240mg/dL
* Availability and willingness to follow study protocol
* Stable body weight for previous 3 months (not more than 5% weight change)
Exclusion Criteria:
* Subjects already on lipid lowering drugs
* LDL-c \> 190 mg/dL
* Total cholesterol \<200 mg/dL and \>240 mg/dL
* Subjects with serum creatinine levels \> 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
* Baseline Triglycerides: \> 300 mg/dL
* Diabetes (Type 1 or Type 2) as diagnosed by a physician
* Uncontrolled hyperthyroidism (as per physician's discretion)
* Uncontrolled hypertension (as per physician's discretion)
* Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history
* Irritable bowel syndrome by history
* Unwillingness to give written informed consent for participation in the study.
* Pregnancy \& lactation (by history)
* Severe end organ damage
* Subjects with allergy to oats
* Heavy smokers (smoking more than 5 cigarettes per day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT02376660
Study Brief:
Protocol Section:
NCT02376660