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
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