Red clover-derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial

ISRCTN	ISRCTN42940165
DOI	https://doi.org/10.1186/ISRCTN42940165
Protocol serial number	N/A
Sponsor	Medical Research Council (UK)
Funders	Novogen Ltd (Australia), Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sheila A. Bingham
Scientific

MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1999

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

MRC Dunn Human Nutrition Unit

Cambridge
CB2 2XY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2004		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes