Red clover-derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial
| ISRCTN | ISRCTN42940165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42940165 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/01/2004
- Registration date
- 30/01/2004
- Last edited
- 02/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sheila A. Bingham
Scientific
Scientific
MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | To determine the effects of taking a red clover-derived isoflavone supplement daily for one year on mammographic breast density. Effects on oestradiol, follicle-stimulating hormone (FSH), luteinising hormone (LH), lymphocyte tyrosine kinase activity and menopausal symptoms were also assessed. |
| Ethics approval(s) | All study procedures were approved by the Dunn Human Nutrition Unit Ethics Committee, and the Cambridge Local Research Ethics Committee. |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Red clover-derived isoflavone tablet (26 mg biochanin A, 16 mg formononetin, 1 mg genistein and 0.5 mg daidzein) or placebo. |
| Intervention type | Supplement |
| Primary outcome measure | Change in: 1. Mammographic breast density 2. Serum oestradiol, FSH and LH 3. Menopausal symptoms 4. Lymphocyte tyrosine kinase activity Measured from baseline to 12 months. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1997 |
| Completion date | 31/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 205 |
| Key inclusion criteria | 1. Women aged 49 - 65 years 2. Wolfe's P2 or DY (dense parenchyma) mammographic breast patterns |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/05/1997 |
| Date of final enrolment | 31/12/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom
CB2 2XY
United Kingdom
Sponsor information
Medical Research Council (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
"ROR" |
https://ror.org/03x94j517 |
|---|
Funders
Funder type
Industry
Novogen Ltd (Australia)
No information available
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2004 | Yes | No |
