The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome

This study has been completed.

Sponsors and Collaborators:	University of Dublin, Trinity College University of Reading University of Oslo Institut National de la Santé Et de la Recherche Médicale, France Maastricht University Medical Center Universidad Nacional de Córdoba Jagiellonian University Uppsala University
Information provided by:	University of Dublin, Trinity College
ClinicalTrials.gov Identifier:	NCT00429195

Purpose

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.

Condition	Intervention
Metabolic Syndrome	Behavioral: Dietary Fatty Acid Modification

MedlinePlus related topics: Dietary Fats

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	LIPGENE Dietary Intervention Study

Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:

IVGTT
Lipoprotein metabolism
Cytokine profiles
Coagulation
Fibrinolysis
Oxidative status

Estimated Enrollment:	480
Study Start Date:	February 2004
Estimated Study Completion Date:	January 2007

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

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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, -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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429195

Locations

Ireland
Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College
Dublin, Ireland, 8

Sponsors and Collaborators

University of Dublin, Trinity College

University of Reading

University of Oslo

Institut National de la Santé Et de la Recherche Médicale, France

Maastricht University Medical Center

Universidad Nacional de Córdoba

Jagiellonian University

Uppsala University

Investigators

Study Director:	Helen M Roche, PhD	University of Dublin, Trinity College
Principal Investigator:	Christine Williams, PhD	University of Reading
Principal Investigator:	Christian Drevon, MD	University of Oslo
Principal Investigator:	Denis Larion, PhD	INSERM, Marseille
Principal Investigator:	Wim Saris, PhD	Maastricht University Medical Center
Principal Investigator:	Jose Lopez Miranda, MD, PhD	Universidad Nacional de Córdoba
Principal Investigator:	Aldona Dembinska-Kiec, MD	The Jagiellonian University Medical College
Principal Investigator:	Bengt Vessby, MD	Uppsala University

More Information

Study website for public information and research collaboration purposes This link exits the ClinicalTrials.gov site

Study ID Numbers:	LIPGENE Dietary Intervention
Study First Received:	January 30, 2007
Last Updated:	January 30, 2007
ClinicalTrials.gov Identifier:	NCT00429195
Health Authority:	Ireland: Irish Medicines Board

Keywords provided by University of Dublin, Trinity College:

LIPGENE
Fatty acid
Dietary intervention
Metabolic syndrome
Insulin resistance

Study placed in the following topic categories:

Insulin Resistance
Insulin

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009