Cardiovascular risk reduction study: supported by an integrated dietary approach

• Register: ISRCTN
• Last refreshed on: 20 February 2017
• Main ID: ISRCTN92382106
• Date of registration: 11/10/2010
• Prospective Registration: No
• Primary sponsor: King's College London (KCL) (UK)
• Public title: Cardiovascular risk reduction study: supported by an integrated dietary approach
• Scientific title: 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
• Date of first enrolment: 16/07/2010
• Target sample size: 196
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN92382106
• Study type: Interventional
• Study design: Randomised parallel-design single-centre controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Thomas Sanders

Key inclusion & exclusion criteria

Inclusion criteria: Healthy men and women, aged 40 - 70 years
Exclusion criteria: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular disease
Circulatory System
Cardiovascular disease

Intervention(s)

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.

Primary Outcome(s)

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.

Secondary Outcome(s)

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

Secondary ID(s)

N02047

Source(s) of Monetary Support

Food Standards Agency (FSA) (UK) (ref: N02047)