Clinical trial NCT00429195: The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
Official title: LIPGENE Dietary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: LIPGENE
Fatty acid
Dietary intervention
Metabolic syndrome
Insulin resistance
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: University of Reading
name: University of Oslo
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Maastricht University Medical Center
name: Universidad Nacional de Córdoba
name: Jagiellonian University
name: Uppsala University
First posted: 2007-01-31
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 reducing dietary SFA consumption, by altering quality of dietary fat and reducing the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic syndrome. Secondly to determine if common genetic polymorphisms affect an individual's responsiveness to dietary therapy.

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) Isocaloric low-fat (28% energy), high-complex carbohydrate diet and (4) Isocaloric low-fat (28% energy), high-complex carbohydrate diet, with 1 g/d LC n-3 PUFA. A 3-day weighed food intake assessed dietary compliance pre-, mid- and post- intervention. An IVGTT, lipoprotein analysis, cytokine, adhesion molecule, coagulation factor and isoprostane levels were determined pre- and post-intervention. DNA, adipose and skeletal muscle biopsies, and PBMC were isolated to characterise nutrient sensitive molecular markers of insulin sensitivity.

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.

Primary outcomes:
measure: IVGTT
measure: Lipoprotein metabolism
measure: Cytokine profiles
measure: Coagulation
measure: Fibrinolysis
measure: Oxidative status
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College
Study officials:
affiliation: University of Dublin, Trinity College
name: Helen M Roche, PhD
role: STUDY_DIRECTOR
affiliation: University of Reading
name: Christine Williams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Christian Drevon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM, Marseille
name: Denis Larion, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Wim Saris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Córdoba
name: Jose Lopez Miranda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Jagiellonian University Medical College
name: Aldona Dembinska-Kiec, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Bengt Vessby, MD
role: PRINCIPAL_INVESTIGATOR
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