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
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

Study website

Contact information

Dr Susan Jebb
Scientific

MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymRISCK
Study objectivesTo 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) studiedMetabolic syndrome and cardiovascular disease risk
InterventionComparison 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Saturated fat (SFA), monounsaturated fat (MUFA), carbohydrate (CHO)
Primary outcome measureInsulin sensitivity from measures of glucose and insulin during an intravenous glucose tolerance test.
Secondary outcome measures1. 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 date01/01/2004
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants650
Key inclusion criteriaMales and females, 30-70 years and at higher metabolic risk (based on a composite scoring system for metabolic syndrome features).
Key exclusion criteria1. 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 enrolment01/01/2004
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom

Sponsor information

MRC Human Nutrition Research (UK)
Research council

Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom

ROR logo "ROR" https://ror.org/050pqs331

Funders

Funder type

Not defined

Food Standards Agency (UK)
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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