Condition category
Circulatory System
Date applied
16/08/2005
Date assigned
19/09/2005
Last edited
23/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.risck.org.uk

Contact information

Type

Scientific

Primary contact

Dr Susan Jebb

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NO2031

Study information

Scientific title

Acronym

RISCK

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Saturated fat (SFA), monounsaturated fat (MUFA), carbohydrate (CHO)

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

650

Participant 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

Recruitment start date

01/01/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom

Sponsor information

Organisation

MRC Human Nutrition Research (UK)

Sponsor details

Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Not defined

Funder name

Food Standards Agency (UK)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19549752
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20739418
3. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21949049
4. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22040870
5. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23964054

Publication citations

  1. Results

    Moore C, Gitau R, Goff L, Lewis FJ, Griffin MD, Chatfield MD, Jebb SA, Frost GS, Sanders TA, Griffin BA, Lovegrove JA, , Successful manipulation of the quality and quantity of fat and carbohydrate consumed by free-living individuals using a food exchange model., J. Nutr., 2009, 139, 8, 1534-1540, doi: 10.3945/jn.108.103374.

  2. Results

    Jebb SA, Lovegrove JA, Griffin BA, Frost GS, Moore CS, Chatfield MD, Bluck LJ, Williams CM, Sanders TA, , Effect of changing the amount and type of fat and carbohydrate on insulin sensitivity and cardiovascular risk: the RISCK (Reading, Imperial, Surrey, Cambridge, and Kings) trial., Am. J. Clin. Nutr., 2010, 92, 4, 748-758, doi: 10.3945/ajcn.2009.29096.

  3. Results

    Alsaleh A, O'Dell SD, Frost GS, Griffin BA, Lovegrove JA, Jebb SA, Sanders TA, , Interaction of PPARG Pro12Ala with dietary fat influences plasma lipids in subjects at cardiometabolic risk., J. Lipid Res., 2011, 52, 12, 2298-2303, doi: 10.1194/jlr.P019281.

  4. Results

    AlSaleh A, Sanders TA, O'Dell SD, Effect of interaction between PPARG, PPARA and ADIPOQ gene variants and dietary fatty acids on plasma lipid profile and adiponectin concentration in a large intervention study., Proc Nutr Soc, 2012, 71, 1, 141-153, doi: 10.1017/S0029665111003181.

  5. Results

    Sanders TA, Lewis FJ, Goff LM, Chowienczyk PJ, , SFAs do not impair endothelial function and arterial stiffness., Am. J. Clin. Nutr., 2013, 98, 3, 677-683, doi: 10.3945/ajcn.113.063644.

Additional files

Editorial Notes