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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01384032
Eligibility Criteria:
Inclusion Criteria:
Men \& women 35-70 years BMI 20-32 kg/m2 Haemoglobin (anaemia): 12.5-18.0g/l (men) and \> 11.5-16g/l (women) Gamma GT (liver function) (\< 80 IU/l), Triglyceride (between 1-4 mmol/l), Plasma total cholesterol (4.5-8 mmol/l) Glucose (World Health organisation recommend \<7 mmol/L).
Exclusion Criteria:
* Females who are breast feeding, may be pregnant, or if child-bearing potential are not taking effective contraceptive precautions
* Likely to alter oral contraceptive or HRT usage during the course of the study
* Blood Pressure \> 160/100 mm Hg (UK guidelines for stage 2 hypertension)
* Had suffered a myocardial infarction or stroke in the previous 12 months
* Hypertensive medication
* Diabetics type I and II
* Any volunteers on a weight reducing diet, or vegan/vegetarians as study requires consumption of dairy products and fish oils
* On high dose fish oil supplements (\> 1g EPA + DHA per day)
* Elevated lipids requiring medication such as statins, fibrates, gall bladder problems or other abnormalities of fat metabolism
* Subjects not willing to make the necessary dietary changes during the study
* Subjects drinking excessive alcohol (UK recommendations/wk currently for men are, no more than 21 units of alcohol per week or more than four units in any one day. For women, no more than 14 units of alcohol per week or more than three units per day).
* Subjects who train at a high level, or attend more than 3 hours organised exercise classes per week
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT01384032
Study Brief:
Protocol Section:
NCT01384032