Plain English Summary
Not provided at time of registration
Study website
Contact information
Type
Scientific
Contact name
Prof Thomas Sanders
ORCID ID
Contact details
Nutritional Science Division
4th Floor
Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
+44 (0)20 7848 4273
tom.sanders@kcl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N02047
Study information
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
Acronym
CRESSIDA
Study hypothesis
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
Study design
Randomised parallel-design single-centre controlled trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Other
Study type
Prevention
Patient information sheet
Can be found at http://www.medscinet.net/CRESSIDA
Condition
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
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 measures
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
Overall study start date
16/07/2010
Overall study end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy men and women, aged 40 - 70 years
Participant type(s)
Healthy volunteer
Age group
Adult
Sex
Both
Target number of participants
196
Participant 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
Recruitment start date
16/07/2010
Recruitment end date
30/06/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Nutritional Science Division
London
SE1 9NH
United Kingdom
Sponsor information
Organisation
King's College London (KCL) (UK)
Sponsor details
Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom
+44 (0)20 7848 6960
keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Industry
Funder name
Food Standards Agency (FSA) (UK) (ref: N02047)
Alternative name(s)
The Food Standards Agency, FSA
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |