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History of Changes for Study: NCT00429195
The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
Latest version (submitted January 18, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 30, 2007 None (earliest Version on record)
2 June 18, 2009 Sponsor/Collaborators, Eligibility and Study Status
3 January 18, 2013 Sponsor/Collaborators, Study Identification and Study Status
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Study NCT00429195
Submitted Date:  January 18, 2013 (v3)

Open or close this module Study Identification
Unique Protocol ID: LIPGENE Dietary Intervention
Brief Title: The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
Official Title: LIPGENE Dietary Intervention Study
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2007
Overall Status: Completed
Study Start: February 2004
Primary Completion:
Study Completion: January 2007
First Submitted: January 30, 2007
First Submitted that
Met QC Criteria:
January 30, 2007
First Posted: January 31, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 18, 2013
Last Update Posted: January 21, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University College Dublin
Responsible Party:
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
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Metabolic Syndrome
Keywords: LIPGENE
Fatty acid
Dietary intervention
Metabolic syndrome
Insulin resistance
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 480
Open or close this module Arms and Interventions
Intervention Details:
Behavioral: Dietary Fatty Acid Modification
Open or close this module Outcome Measures
Primary Outcome Measures:
1. IVGTT
2. Lipoprotein metabolism
3. Cytokine profiles
4. Coagulation
5. Fibrinolysis
6. Oxidative status
Open or close this module Eligibility
Minimum Age: 35 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Helen M Roche, PhD
Study Director
University of Dublin, Trinity College
Christine Williams, PhD
Principal Investigator
University of Reading
Christian Drevon, MD
Principal Investigator
University of Oslo
Denis Larion, PhD
Principal Investigator
INSERM, Marseille
Wim Saris, PhD
Principal Investigator
Maastricht University
Jose Lopez Miranda, MD, PhD
Principal Investigator
Universidad de Córdoba
Aldona Dembinska-Kiec, MD
Principal Investigator
The Jagiellonian University Medical College
Bengt Vessby, MD
Principal Investigator
Uppsala University
Locations: Ireland
Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College
Dublin, Ireland, 8
Open or close this module IPDSharing
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