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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00051402 |
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.
Condition | Intervention | Phase |
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Memory Loss Postmenopause |
Drug: Isoflavones |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phytoestrogens and Cognition in Menopause |
Estimated Enrollment: | 96 |
Study Start Date: | December 2002 |
Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 62 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exlcusion Criteria
United States, Ohio | |
University of Cincinnati College of Medicine | |
Cincinnati, Ohio, United States, 45267-0559 |
Principal Investigator: | Robert Krikorian, PhD | University of Cincinnati |
Study ID Numbers: | R21 AT000567-01A1 |
Study First Received: | January 9, 2003 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00051402 |
Health Authority: | United States: Federal Government |
Postmenopausal Memory Loss Cognition Phytoestrogens |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dementia Neurobehavioral Manifestations |
Memory Disorders Menopause Cognition Disorders Amnesia Delirium |
Nervous System Diseases |