Cardiovascular risk reduction study: supported by an integrated dietary approach
| ISRCTN | ISRCTN92382106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92382106 |
| Protocol serial number | N02047 |
| Sponsor | King's College London (KCL) (UK) |
| Funder | Food Standards Agency (FSA) (UK) (ref: N02047) |
- Submission date
- 04/08/2010
- Registration date
- 11/10/2010
- Last edited
- 19/01/2017
- 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
Prof Thomas Sanders
Scientific
Scientific
Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised parallel-design single-centre controlled trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | CRESSIDA |
| Study objectives | An integrated dietary approach using a cardioprotective diet will significantly reduce cardiovascular disease (CVD) risk factors compared to the average UK diet. |
| Ethics approval(s) | St. Thomas' Hospital Research Ethics Committee, April 2010, ref: 10/H0802/24 |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(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. |
| Key secondary outcome measure(s) |
1. A change in arterial stiffness (pulse wave velocity and digital volume pulse), measured at baseline and 3 months |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 196 |
| Key inclusion criteria | Healthy men and women, aged 40 - 70 years |
| Key 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 |
| Date of first enrolment | 16/07/2010 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Nutritional Science Division
London
SE1 9NH
United Kingdom
SE1 9NH
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 | 01/05/2015 | Yes | No | |
| Results article | results | 01/04/2017 | Yes | No | |
| Results article | results | 01/06/2017 | 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 |
Editorial Notes
19/01/2017: Publication reference added.
11/01/2015: Publication reference added.
