Clinical Trials Directory

Trials / Completed

CompletedNCT00429195

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

LIPGENE Dietary Intervention Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
480 (planned)
Sponsor
University College Dublin · Academic / Other
Sex
All
Age
35 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDietary Fatty Acid Modification

Timeline

Start date
2004-02-01
Completion
2007-01-01
First posted
2007-01-31
Last updated
2013-01-21

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT00429195. Inclusion in this directory is not an endorsement.