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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
University of Cordoba
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   

ChemIDplus related topics:   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
University of Cordoba
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     University of Cordoba    
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
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 October 03, 2008




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