Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29111298
Enrollment
650
Registered
2005-09-19
Start date
2004-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome and cardiovascular disease risk Circulatory System Other metabolic disorders

Interventions

low fat, low GI) with a control group (SFA intake typical of the UK habitual diet)
high MUFA, low GI
low fat, high GI
Comparison of four experimental diets (high MUFA, high glycemic index [GI]

Sponsors

MRC Human Nutrition Research (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Insulin sensitivity from measures of glucose and insulin during an intravenous glucose tolerance test.

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026