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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Dietary 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.