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ISRCTN
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ISRCTN92382106
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ClinicalTrials.gov identifier
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Public title
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Cardiovascular risk REduction Study: Supported by an Integrated Dietary Approach
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Scientific title
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The effectiveness of an integrated cardioprotective dietary intervention compared with an average UK diet in reducing cardiovascular disease risk factors in older men and women aged 40 - 70 years
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Acronym
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CRESSIDA
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Serial number at source
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N02047
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Study hypothesis
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An integrated dietary approach using a cardioprotective diet will significantly reduce cardiovascular disease (CVD) risk factors compared to the average UK diet.
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Lay summary
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Ethics approval
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St. Thomas' Hospital Research Ethics Committee approved the study in April 2010 (ref: 10/H0802/24)
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Study design
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Randomised parallel design single-centre controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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Healthy men and women, aged 40 - 70 years
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Participants - exclusion criteria
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1. A reported history of angina, myocardial infarction, peripheral vascular disease, congenital heart disease or stroke
2. Asymptomatic atrial fibrillation
3. Type 1 or type 2 diabetes mellitus (fasting plasma glucose greater than 7 mmol/L)
4. Seated blood pressure greater than 160/105 mmHg
5. Current use of medication for lowering blood cholesterol (statins) or blood pressure
6. Body mass index less than 18.5 and greater than 35 kg/m2
7. An overall risk of cardiovascular disease over the next ten years of greater than 20% assessed according to current NICE guidelines in combination with untreated high blood pressure or raised cholesterol
8. Clinical history of cancer (excluding basal cell carcinoma) in the past five years
9. Chronic renal, liver or inflammatory bowel disease
10. Current cigarette smoker (confirmed by urinary cotinine analysis)
11. History of substance abuse or alcoholism (previous weekly alcohol intake greater than 60 units/men or 50 units/women)
12. Current self-reported weekly alcohol intake not exceeding 21 units for women and 28 for men
13. Currently pregnant, planning pregnancy or having had a baby in the last 12 months
14. Unwilling to follow the protocol and/or give informed consent
15. Unwilling to refrain from use of dietary supplements
16. Unwilling to restrict consumption of oily fish
17. Weight change of greater than 3 kg in preceding 2 months
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Anticipated start date
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16/07/2010
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Anticipated end date
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30/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Can be found at http://www.medscinet.net/CRESSIDA
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Target number of participants
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196
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Interventions
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This is a controlled dietary intervention trial comparing a cardioprotective diet (decreased salt and saturated fatty acids intake, and increased wholegrain cereals, fruit and vegetables and oily fish intake) with a control diet (average UK diet) for 3 months.
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Primary outcome measure(s)
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A change in systolic blood pressure (BP) measured by ambulatory blood pressure, a change in endothelial function measured by flow-mediated dilation, and a change in total/high density lipoprotein (HDL) cholesterol ratio measured at baseline and 3 months.
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Secondary outcome measure(s)
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1. A change in arterial stiffness (pulse wave velocity and digital volume pulse), measured at baseline and 3 months
2. A change in insulin sensitivity (revised quantitative insulin sensitivity test [RQUICKI] and serum adiponectin), measured at baseline and 3 months
3. A change in C-reactive protein concentrations, measured at baseline and 3 months
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Sources of funding
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Food Standards Agency (FSA) (UK) (ref: N02047)
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Trial website
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http://www.medscinet.net/CRESSIDA/
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Publications
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Contact name
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Prof
Thomas
Sanders
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Address
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Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
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City/town
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London
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 4273
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Fax
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+44 (0)20 7848 4171
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Email
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tom.sanders@kcl.ac.uk
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Sponsor
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King's College London (KCL) (UK)
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Address
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Room 1.8, Hodgkin Building
Guy's Campus
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City/town
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London
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Zip/Postcode
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SE1 1UL
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 6960
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Fax
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+44 (0)20 7848 6394
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Email
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keith.brennan@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk
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Date applied
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04/08/2010
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Last edited
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11/10/2010
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Date ISRCTN assigned
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11/10/2010
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