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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01530893
Eligibility Criteria:
Inclusion Criteria:
* Males
* 50 to 75 years old
* At elevated risk of CV disease
* Screening blood pressure of \< 160/90mmHg (at rest)
* Successful biochemical, haematological and urinalysis assessment at screening (as judged by clinical advisor)
Exclusion Criteria:
* Current smokers, or ex-smokers ceasing \< 3 months ago
* Subjects with existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures (as judged by clinical advisor)
* Those with known allergies to the intervention treatments
* Those unprepared to adhere to dietary restrictions during the trial
* Parallel participation in another research project which involves concurrent dietary intervention and/or sampling of biological fluids/material
* Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
* Taking flavonoid containing food / dietary supplements likely to affect the study results
* Prescribed lipid lowering, hypertension, vasodilators (e.g. Viagra) or antibiotic medication
* Unsatisfactory biochemical, haematological or urinary assessment at screening, indicating abnormal; renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT01530893
Study Brief:
Protocol Section:
NCT01530893