Extract

Background and study aims: Soy (a vegetable foodstuff) contains chemicals called phyto-oestrogens (isoflavones) that have been shown to be of potential benefit to people during menopause as soy can alleviate menopausal hot flushes. It has also been shown that bones lose their density more rapidly during the immediate years following menopause. It is not really known if soy can have an effect on chemicals in the blood that reflects bone loss and growth. Therefore it is important to compare the effect of soy proteins, with and without phyto-oestrogens, on the bone health of women during this time. This study aims to look at the effects of eating snack bars containing soy protein, with or without phyto-oestrogens, during the first two years of menopause. This will be done in such a way that neither the individual taking part, nor the investigator will know which type of bars the person has been eating. Who can participate? Women who have experienced menopause within the last 2 years What does the study involve? Participants will be asked to visit the research department a total of four times over a period of 6 months. They will also be contacted by telephone twice within this 6 month period. The first visit, that will last about 30 minutes, will involve discussing the study and signing a consent form. The subsequent visits will last around an hour. 1. At the second, third and final visit the participants will be asked to attend the clinic first thing in the morning, having fasted overnight. The blood samples will be tested for hormone levels and bone turn over makers. 2. At the second, third and final visit the participants will have an ultrasound scan examination of the lining of your womb. 3. At the second visit the participants will be given enough soy snack bars to eat twice a day (mid morning and mid afternoon) for 3 months. What are the possible benefits and risks of participating? Although there may be some direct benefits to some people taking part in the study, these will not be known until the study has finished. It is hoped that this study will help to provide the information needed to inform the Food Standards Agency and UK governments regarding the safety and potential benefits of eating soy and phytooestrogens to women during menopause. Where is the study run from? The University of Hull at Brocklehurst Building of Hull Royal Infirmary. When is study starting and how long is it expected to run for? The study started in July 2010 and will end in December 2012 Who is funding the study? Food Standard Agency, UK Who is the main contact? Prof Stephen Atkin [email protected]

Inclusion criteria

• Effect of soy phyto-eastrogens to people during menopause as soy have been shown to improve menopausal flusing symptoms

Links

• ictrp
• isrctn