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Soy Bean

6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days)

6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days)

6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC

Soy and Selenium

Aedin Cassidy, PhD

There is evidence to suggest that some dietary components can reduce the risk of breast cancer. In this pilot study two such components, isoflavones (compounds found in soy products) and selenium, will be given to women classed as at moderate to high risk of the disease. The aim is to determine some novel biomarkers of risk and to see the effect of supplementation on them.

The high incidence of breast cancer, its relatively long development phase and the financial burden to the NHS in relation to treatment makes it a prime target for dietary preventative strategies. Epidemiological and experimental investigations suggest several key dietary components that may reduce breast cancer, in particular isoflavones and selenium. Few dietary intervention studies have been conducted to investigate putative protective effects, but with our growing understanding of cancer biology and the application of new -omics technologies it is now possible to use early biomarkers of risk to assess the potential efficacy of intervention studies.

In this pilot project, we will employ a combination of disciplines to examine the effect of dietary intervention in a group of women defined by NICE guidelines as being at increased risk (moderate-high) of developing breast cancer, using metabolomics to assess the tractability of biomarkers in response to the dietary intervention. Such trials are urgently needed to examine the protective effects of diet in women classified at increased risk and who are still in the 'zone of reversibility'. The results of this study will be used to justify and optimise larger scale intervention trials and ultimately to develop appropriate dietary recommendations for the prevention of breast cancer.

A dietary intervention study based on a randomised double-blind parallel design will be conducted in 30 pre-menopausal women (age 35-50) at moderate to high risk of developing breast cancer. The metabolomic profiles of urine and serum samples (collected at baseline and after dietary intervention) will be assessed. Participants will be randomised into two groups; the placebo group (consuming 6g of non-supplemented chocolate per day) and the supplemented group (consuming 6g of chocolate containing both soy and selenium per day). The intervention will last for the duration of one menstrual cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Soy, Selenium and Breast Cancer Risk	NCT00555386	Breast Cancer R...	Soy and Seleniu...	35 Years - 50 Years	University of East Anglia
Soy, Selenium and Breast Cancer Risk	NCT00555386	Breast Cancer R...	Soy and Seleniu...	35 Years - 50 Years	University of East Anglia

Spots Global Cancer Trial Database for soy and selenium