Impact of the amount and composition of dietary fat and carbohydrate on metabolic syndrome and cardiovascular disease risk

Completed

Conditions: Metabolic syndrome and cardiovascular disease risk
Circulatory System
Other metabolic disorders

Registration Number: ISRCTN29111298

Lead Sponsor: MRC Human Nutrition Research (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 650

Inclusion Criteria

Males and females, 30-70 years and at higher metabolic risk (based on a composite scoring system for metabolic syndrome features).

Exclusion Criteria

1. History of the following conditions/treatments
1.1. myocardial infarction
1.2. cancer
1.3. diabetes mellitus
1.4. cholestatic liver disease or pancreatitis
1.5. chronic coronary, renal or bowel disease
1.6. gastrointestinal disorders
1.7. hypolipidemic therapy
1.8. systemic corticosteroids
1.9. androgens
1.10. phenytoin
1.11. erythromycin
1.12. heamostatic drugs (excluding aspirin)
2. Smokers >20/day
3. History of substance abuse or alcoholism
4. Pregnancy, planning pregnancy or 12-months post-partum
5. Allergy or intolerance to study foods
6. Recent weight change
7. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) >1 g/day

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity from measures of glucose and insulin during an intravenous glucose tolerance test.

Secondary Outcome Measures

Name	Time	Method
1. Fasting lipid profile<br>2. Vascular reactivity and endothelial function<br>3. Haemostatic factors<br>4. Markers of the inflammatory response<br>5. Leptin and adiponectin<br>6. Urinary microalbumin to creatinine ratio<br>7. Plasma fatty acid composition<br>8. DNA for nutrient-gene interactions