Status:
COMPLETED
The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
Lead Sponsor:
University College Dublin
Collaborating Sponsors:
University of Reading
University of Oslo
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief Summary
The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded, randomised, controlled trial with two principal aims. Firstly to determine the relative efficacy of reducin...
Detailed Description
521 free-living subjects with the metabolic syndrome received one of four dietary treatments for 12 weeks: (1) High-fat (38% energy) SFA-rich diet; (2) High-fat (38% energy), MUFA-rich diet; (3) Isoca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00429195
Start Date
February 1 2004
End Date
January 1 2007
Last Update
January 21 2013
Active Locations (1)
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1
Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College
Dublin, Dublin, Ireland, 8