Condition category
Circulatory System
Date applied
04/08/2010
Date assigned
11/10/2010
Last edited
11/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medscinet.net/CRESSIDA/

Contact information

Type

Scientific

Primary contact

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 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

St. Thomas' Hospital Research Ethics Committee approved the study in 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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

16/07/2010

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy men and women, aged 40 - 70 years

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
+44 (0)20 7848 6960
keith.brennan@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25787998
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26746219

Publication citations

Additional files

Editorial Notes

11/01/2015: Publication reference added.