The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
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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 |
- IVGTT
- Lipoprotein metabolism
- Cytokine profiles
- Coagulation
- Fibrinolysis
- Oxidative status
| 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.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Ireland | |
| Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College | |
| Dublin, Ireland, 8 | |
| 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:
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013