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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT01735357
Eligibility Criteria:
Inclusion Criteria:
* Healthy males
* No smokers
* Aged 18-45y old
* Able to understand the information sheet and comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.
Exclusion Criteria:
* Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke, dyslipidemia), diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
* Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
* Current smokers; history of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/week); current self-reported weekly alcohol intake exceeding 28 units
* Recent use of hypolipidaemic, antihypertensive, antiplatelet or antithrombotic mediations
* Platelet count above or below the normal range or any history indicative of a congenital or acquired platelet or haemostatic defect.
* Allergy or intolerance to any component of study capsules
* Unwilling to restrict consumption of any source of fish oil for the length of the study
* Subjects reporting consumption of \>1 portion oily fish per week
* Weight change of \>3 kg in preceding 2 months; BMI \<18 and \>32 kg/m2
* Blood pressure\>160/90 mmHg
* Fasting blood cholesterol \> 6.5 mmol/L; fasting triacylglycerol concentrations \> 2.0 mmol/L
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01735357
Study Brief:
Protocol Section:
NCT01735357