Condition category
Circulatory System
Date applied
19/02/2009
Date assigned
31/03/2009
Last edited
07/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Moore

ORCID ID

Contact details

Primary Medical Care
Aldermoor Close
Southampton
SO16 1ST
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4/3/03

Study information

Scientific title

An open randomised trial of the effect of plant sterol margarines on serum cholesterol in everyday practice

Acronym

SPREADS

Study hypothesis

1. To estimate the effect of advice to use a plant sterol margarine in a free living population when compared to a polyunsaturated margarine among those with hypercholesterolaemia.
2. To estimate whether sterols reduce beta-carotene levels and if this can be counteracted by an increase in fruit and vegetable consumption.

Ethics approval

1. South Wiltshire Ethics Committee, approved in 2002, ref: SA231/2002
2. Southampton City Ethics Committee, approved in 2002, ref: 328/02/w

Study design

Open randomised crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Hypercholesterolaemia in adults

Intervention

Polyunsaturated margarine or sterol enriched margarine taken for 6 weeks with a crossover design (no washout period).

Total duration of interventions and follow-up: 12 weeks

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Serum cholesterol and beta-carotene.

All primary and secondary outcomes were assessed at baseline, 6 and 12 weeks.

Secondary outcome measures

High-density lipoprotein (HDL) cholesterol, total cholesterol (TC)/HDL ratio.

All primary and secondary outcomes were assessed at baseline, 6 and 12 weeks.

Overall trial start date

01/09/2003

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adult (both males and females) over 18 with cholesterol >6 mmol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

232

Participant exclusion criteria

Those considered unsuitable by their GP e.g., cancer, acute or chronic psychotic disorder or dementia

Recruitment start date

01/09/2003

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO16 1ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

University Road
Southampton
so17 1bj
United Kingdom

Sponsor type

University/education

Website

http://www.soton.ac.uk/

Funders

Funder type

University/education

Funder name

Royal College of General Practitioners (RCGP) - Scientific Foundation Board (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes