Postmenopause Clinical Trial
Official title:
Phytoestrogens and Cognition in Menopause
The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.
Accumulating data has indicated that estrogens mediate enhancing effects on cognition and
mood and may play a prophylactic role against age- and disease-related cognitive-cerebral
decline. Phytoestrogens are plant-derived substances that have demonstrated estrogenic
activity, but there is little prospective research regarding their effects on mental
function. Mental health practitioners generally do not prescribe phytoestrogens. However,
many women experiencing peri- and post-menopausal symptoms use marketed phytoestrogens under
the perception of general health benefits, including presumably enhanced mental function.
The purpose of this study is to develop preliminary data regarding the efficacy of
isoflavone phytoestrogens in improving cognitive function in late middle-aged and elderly
postmenopausal women with symptoms of memory impairment.
Participants in this study will be randomized to receive either isoflavone supplementation
or placebo. The study will last for 16 weeks, during which participants will take the
supplement pill or placebo three times a day. Participants will be assessed at study entry
and at Week 16 for changes in basal cortisol levels, mood, and neuropsychological measures
of executive function ability and episodic memory.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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