Effect of plant sterol margarines on serum cholesterol in everyday practice
| ISRCTN | ISRCTN61150880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61150880 |
| Protocol serial number | 4/3/03 |
| Sponsor | University of Southampton (UK) |
| Funder | Royal College of General Practitioners (RCGP) - Scientific Foundation Board (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open randomised crossover trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) |
Serum cholesterol and beta-carotene assessed at baseline, 6 and 12 weeks |
| Key secondary outcome measure(s) |
High-density lipoprotein (HDL) cholesterol, total cholesterol (TC)/HDL ratio, assessed at baseline, 6 and 12 weeks |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Primary Medical Care
Southampton
SO16 1ST
United Kingdom
SO16 1ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/10/2017: No publications found, verifying study status with principal investigator.
