Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
All study procedures were approved by the Dunn Human Nutrition Unit Ethics Committee, and the Cambridge Local Research Ethics Committee.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Red clover-derived isoflavone 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 trial start date
01/05/1997
Overall trial end date
31/12/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 49 - 65 years
2. Wolfe's P2 or DY (dense parenchyma) mammographic breast patterns
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
205
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/05/1997
Recruitment end date
31/12/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom
Funders
Funder type
Industry
Funder name
Novogen Ltd (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15084240
Publication citations
-
Results
Atkinson C, Warren RM, Sala E, Dowsett M, Dunning AM, Healey CS, Runswick S, Day NE, Bingham SA, Red-clover-derived isoflavones and mammographic breast density: a double-blind, randomized, placebo-controlled trial [ISRCTN42940165]., Breast Cancer Res., 2004, 6, 3, R170-9, doi: 10.1186/bcr773.