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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT00422266
Eligibility Criteria:
Inclusion Criteria:
* Male subjects aged between 35-55 years.
* Total cholesterol (TC) between 5.0 - 8.0 mmol/L.
* Body Mass Index (BMI) is between 18-30 kg/m2.
* Willing to consume the intervention product.
* Willing to participate in the study and perform all measurements including. blood drawing, anthropometry, dietary assessment and questionnaires.
* Informed consent signed by subject.
Exclusion Criteria:
* Smokers (more than 10 cigarettes per day).
* Heavy drinker (more than 6 large pegs or 360 ml of 40% alcohol per week).
* Triglycerides \> 4.0 mmol/L.
* Individuals with chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke, diabetes, chronic renal failure, gastrointestinal disease, metabolic diseases (eg. thyroid, pancreas) and people with a compromised GI function like after extensive bowel resections.
* Fasting blood glucose \> 120mg/dl and glycosylated hemoglobin \> 7.5%.
* Individuals on medication (e.g.: insulin, oral hypoglycemic drugs, beta blockers, steroids or lipid-lowering drugs) or dietary supplements known to alter lipid and/or glucose metabolism during the study, including plant sterol-enriched foods and fish oil supplements, or having used these substances in 3 months preceding the intervention period.
* Reported participation in another biomedical trial 3 months before the start of the study or during the study.
* Reported weight loss / gain (10% or more) during the last 6 months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
55 Years
Study:
NCT00422266
Study Brief:
Protocol Section:
NCT00422266