Cardiovascular risk reduction study: supported by an integrated dietary approach

ISRCTN	ISRCTN92382106
DOI	https://doi.org/10.1186/ISRCTN92382106
Secondary identifying numbers	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

Not provided at time of registration

Study website

Contact information

Prof Thomas Sanders
Scientific

Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom

Phone	+44 (0)20 7848 4273
Email	tom.sanders@kcl.ac.uk

Study information

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
Participant information sheet	Can be found at http://www.medscinet.net/CRESSIDA
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 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
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

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	196
Participant inclusion criteria	Healthy men and women, aged 40 - 70 years
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

King's College London (KCL) (UK)
University/education

Room 1.8, Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom

Phone	+44 (0)20 7848 6960
Email	keith.brennan@kcl.ac.uk
Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Industry

Food Standards Agency (FSA) (UK) (ref: N02047)
Private sector organisation / Other non-profit organizations

Alternative name(s): The Food Standards Agency, FSA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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

Editorial Notes

19/01/2017: Publication reference added.
11/01/2015: Publication reference added.