Impact of the amount and composition of dietary fat and carbohydrate on metabolic syndrome and cardiovascular disease risk
| ISRCTN | ISRCTN29111298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29111298 |
| Protocol serial number | NO2031 |
| Sponsor | MRC Human Nutrition Research (UK) |
| Funder | Food Standards Agency (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Saturated fat (SFA), monounsaturated fat (MUFA), carbohydrate (CHO) |
| Primary outcome measure(s) |
Insulin sensitivity from measures of glucose and insulin during an intravenous glucose tolerance test. |
| Key secondary outcome measure(s) |
1. Fasting lipid profile |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
CB1 9NL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
