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.
Description
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.
Status: Completed (Phase 2). Started on December 1st, 2002. Ended on August 1st, 2007.
Enrollment: 96 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Double-Blind
- Placebo Control
- Parallel Assignment
- Efficacy Study
Conditions:
Interventions:
- Drug: Isoflavones
Eligibility
Inclusion Criteria
Postmenopausal women
Mild memory or cognitive decline that does not meet the criteria for probable dementia
Exlcusion Criteria
Hormone replacement therapy within 2 months prior to study entry
Psychiatric medications within 30 days prior to study entry
- Gender
Female
- Mininum Age
62 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: National Center for Complementary and Alternative Medicine (NCCAM)
Authority: United States: Federal Government
Locations
-
University of Cincinnati College of Medicine
Cincinnati
Ohio
45267-0559
United States
Officials
Robert Krikorian, PhD (Principal Investigator, University of Cincinnati)
Sponsors
National Center for Complementary and Alternative Medicine (NCCAM) (Lead Sponsor)
References
None.
Links
- Date Verified
- October 1st, 2007
- First Received
- October 24th, 2007
- Last Changed
- October 24th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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