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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT00429195
Eligibility Criteria:
Inclusion Criteria:
* Gender: males and females (not pregnant or lactating).
* Body Mass Index (BMI) 20-40 kg/m2
* Total cholesterol concentration equal to or \< 8.0 mmol/l.
* Medications / nutritional supplements allowed, on condition that the subjects adhere to the same regimen during the intervention: anti-hypertensive medication (including beta-blockers), oral contraceptives, hormone replacement therapy, multi-vitamin supplements, other non-fatty acid based nutritional supplements (e.g. garlic, anti-oxidants, etc).
* Smokers and non-smokers.
* Regular consumers of alcohol, which is not excessive as defined by elevated liver enzymes (AST and ALT).
* Ethnicity: Intention to include white Europeans.
Exclusion Criteria:
* Diabetes or other endocrine disorders.
* Chronic inflammatory conditions.
* Kidney or liver dysfunction.
* Iron deficiency anaemia (haemoglobin \< 12g/dl men, \< 11g/dl women)
* Prescribed hypolipidaemic medication
* Prescribed anti-inflammatory medication
* Fatty acid supplements including fish oils, evening primrose oil, etc.
* Consumers of high doses of antioxidant vitamins (A, C, E, beta-carotene).
* Red rice yeast (Monascus purpureus) supplement usage.
* High consumers of oily fish (\> 2 serving of oily fish per week of herring, mackerel, kippers, pilchards, sardines, salmon, trout, tuna (fresh), crabmeat or marlin). One portion is defined as a small herring or mackerel, one can of salmon or sardines or one salmon or tuna steak. Tinned tuna is permitted as it contains only minor amounts of long chain n-3 PUFAs.
* Highly trained or endurance athletes or those who participate in more than 3 periods of intense exercise per week.
* Volunteers planning to start a special diet or loose weight (e.g. the Slimfast Plan, Atkins Diet etc).
* Weight change equal or \>3kg within the last 3 months.
* Alcohol or drug abuse (based on clinical judgement).
* Pregnant / lactating females / women planning a pregnancy in the next 12 months. Women who become pregnant during the dietary intervention period should be removed from the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT00429195
Study Brief:
Protocol Section:
NCT00429195