Impact of the amount and composition of dietary fat and carbohydrate on metabolic syndrome and cardiovascular disease risk
ISRCTN | ISRCTN29111298 |
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DOI | https://doi.org/10.1186/ISRCTN29111298 |
Secondary identifying numbers | NO2031 |
- Submission date
- 16/08/2005
- Registration date
- 19/09/2005
- Last edited
- 23/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susan Jebb
Scientific
Scientific
MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study acronym | RISCK |
Study objectives | To test whether the replacement of saturated fat (SFA) with monounsaturated fat (MUFA), compared with carbohydrate (CHO), will result in improved insulin sensitivity in adults with features of the metabolic syndrome; and whether CHO quality will influence the relative health impact of both the MUFA-rich and CHO-rich diet regimens. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Metabolic syndrome and cardiovascular disease risk |
Intervention | Comparison of four experimental diets (high MUFA, high glycemic index [GI]; high MUFA, low GI; low fat, high GI; low fat, low GI) with a control group (SFA intake typical of the UK habitual diet) |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Saturated fat (SFA), monounsaturated fat (MUFA), carbohydrate (CHO) |
Primary outcome measure | Insulin sensitivity from measures of glucose and insulin during an intravenous glucose tolerance test. |
Secondary outcome measures | 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 |
Overall study start date | 01/01/2004 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 650 |
Key inclusion criteria | Males and females, 30-70 years and at higher metabolic risk (based on a composite scoring system for metabolic syndrome features). |
Key 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 |
Date of first enrolment | 01/01/2004 |
Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
CB1 9NL
United Kingdom
Sponsor information
MRC Human Nutrition Research (UK)
Research council
Research council
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
https://ror.org/050pqs331 |
Funders
Funder type
Not defined
Food Standards Agency (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/08/2009 | Yes | No | |
Results article | results | 01/10/2010 | Yes | No | |
Results article | results | 01/12/2011 | Yes | No | |
Results article | results | 01/02/2012 | Yes | No | |
Results article | results | 01/09/2013 | Yes | No |