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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT01478958
Eligibility Criteria:
Inclusion Criteria:
Adults should have a relative risk (RR) of \> 1.5 of developing cardiovascular disease (CVD) based on presenting with at least one recognised risk factor for CVD:
* total cholesterol (TC) \> 6.0 mmol/l
* HDL cholesterol (HDLC) ≤ 1.0 mmol/l male, ≤ 1.3 mmol/l female
* Glucose ≥ 6 mmol/l
* Stage 1 hypertension or above i.e. a systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg
* BMI 28-35 kg/m2
* waist \>102 cm male or \> 84 cm female
* Adults with a first degree relative with either a history of premature CVD - age of onset younger than 55 y in fathers, sons or brothers or younger than 65 y in mothers, daughters or sisters, or type 2 diabetes.
Exclusion Criteria:
* having suffered a myocardial infarction/stroke in the past 12 months
* diabetic (diagnosed or fasting glucose \> 7 mmol/l) or suffer from other endocrine disorders
* suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
* on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* no history of alcohol abuse
* planning or on a weight reducing regime
* taking any fish oil, fatty acid or vitamin and mineral supplements
* pregnant, lactating or planning a pregnancy
* smokers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT01478958
Study Brief:
Protocol Section:
NCT01478958