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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01916434
Eligibility Criteria:
Inclusion criteria: Healthy men and women aged 35-75 years BMI ranging from 18-35 kg/m2 Blood pressure below 160/90 mmHg; Total cholesterol \< 8.00 mmol/L Total/HDL cholesterol \< 6 mmol/L Fasting plasma glucose , 7 mmol/L Having a 10-20% risk for developing cardiovascular disease within the next 10 years based on the ASSIGN calculation (http://cvrisk.mvm.ed.ac.uk/index.htm) including the following factors: age, gender, number of cigarettes smoked per day, Scottish Index of Multiple Deprivation (SIMD)/postcode, systolic blood pressure, levels of total and HDL cholesterol and family history of cardiovascular disease, or having at least one additional risk factor such as being over 50 years old, BMI above 25 kg/m2, elevated triglyceride levels (\> 1.7 mmol/L) or elevated glucose levels (\> 5.6 mmol/L); platelet count \> 1709/L haematocrit above 40 % for males and above 35 % for females haemoglobin above 130 g/L for males and above 115 g/L for females
Exclusion criteria Regularly taking aspirin or aspirin-containing drugs, or other anti-inflammatory drugs; Taking drugs or herbal medicines known to alter the haemostatic system in general; Taking any medicine known to affect lipid metabolism; Taking certain dietary supplements/multivitamin tablets; Diagnosis of diabetes, hypertension, renal, hepatic, haematological disease or coronary heart disease; Unsuitable veins for blood sampling; Inability to understand the participant information sheet; inability to speak, read and understand the English language.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT01916434
Study Brief:
Protocol Section:
NCT01916434