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

This study has been completed.
Sponsor:
Collaborators:
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 College Dublin
ClinicalTrials.gov Identifier:
NCT00429195
First received: January 30, 2007
Last updated: January 18, 2013
Last verified: January 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: LIPGENE Dietary Intervention Study

Resource links provided by NLM:


Further study details as provided by University College Dublin:

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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 College Dublin
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
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

Additional Information:
No publications provided by University College Dublin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00429195     History of Changes
Other Study ID Numbers: LIPGENE Dietary Intervention
Study First Received: January 30, 2007
Last Updated: January 18, 2013
Health Authority: Ireland: Irish Medicines Board

Keywords provided by University College Dublin:
LIPGENE
Fatty acid
Dietary intervention
Metabolic syndrome
Insulin resistance

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014