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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 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | LIPGENE Dietary Intervention Study |
Estimated Enrollment: | 480 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | January 2007 |
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.
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Ireland | |||||
Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College | |||||
Dublin, Ireland, 8 |
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 |
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 |
Study website for public information and research collaboration purposes 
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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 |
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