Effect of plant sterol margarines on serum cholesterol in everyday practice
| ISRCTN | ISRCTN61150880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61150880 |
| Secondary identifying numbers | 4/3/03 |
- Submission date
- 19/02/2009
- Registration date
- 31/03/2009
- Last edited
- 13/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Moore
Scientific
Scientific
Primary Medical Care
Aldermoor Close
Southampton
SO16 1ST
United Kingdom
Study information
| Study design | Open randomised crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An open randomised trial of the effect of plant sterol margarines on serum cholesterol in everyday practice |
| Study acronym | SPREADS |
| Study objectives | 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(s) | 1. South Wiltshire Ethics Committee, approved in 2002, ref: SA231/2002 2. Southampton City Ethics Committee, approved in 2002, ref: 328/02/w |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Serum cholesterol and beta-carotene assessed at baseline, 6 and 12 weeks |
| Secondary outcome measures | High-density lipoprotein (HDL) cholesterol, total cholesterol (TC)/HDL ratio, assessed at baseline, 6 and 12 weeks |
| Overall study start date | 01/09/2003 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 232 |
| Key inclusion criteria | Adult (both males and females) over 18 with cholesterol >6 mmol |
| Key exclusion criteria | Those considered unsuitable by their GP e.g., cancer, acute or chronic psychotic disorder or dementia |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Medical Care
Southampton
SO16 1ST
United Kingdom
SO16 1ST
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
University Road
Southampton
so17 1bj
England
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
University/education
Royal College of General Practitioners (RCGP) - Scientific Foundation Board (UK)
No information available
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 |
Editorial Notes
13/10/2017: No publications found, verifying study status with principal investigator.
