The EPSA ANS was asked to deliver a scientific opinion on the possible
association between the intake of isoflavones from food supplements and
harmful effects on mammary gland, uterus and thyroid in peri- and
post-menopausal women. Isoflavones are naturally occurring substances
which can be found in, among other sources, soy, red clover and kudzu
root. The main isoflavones are genistein, daidzein, glycitein,
formononetin, biochanin A and puerarin. Their chemical structures are
related to 17B-oestradiol and they possess oestrogenic properties.
Furthermore, isoflavones may interact with the synthesis of thyroid
hormone. Food supplements targeted at peri- and post- menopausal women
typically provide a daily dose of isoflavones in the range of 35-150
mg/day. A systematic review was performed to investgigate whether an
association could be found between intake of isoflavones from food
supplements and adverse effects on the three target organs in peri- and
post- menopausal women. The human data did not support the hypothesis of
an increased risk of breast cancer from observational changes in the
uterus up to 30 months of supplementation with 150 mg/day of soy
isoflavones. After 60 months some non-malignant histopathological
changes were reported. ÇThyroid hormones levels were not changed
following intake of isoflavones from food supplements. The background
exposure from the diet in the general European population was estimated
to be lower than 1 mg/day, whereas in consumers of soy-based foods it
could be higher. The Panel concluded that it was not possible to derive a
single health-based guidance value for the different preparations in
port-menopausal women. However the doses used in the intervention
studies and their duration could serve as guidance for the intake of
food supplements.
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