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Phytoestrogens and Memory Decline in Menopause
This study has been completed.
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00051402
  Purpose

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
Memory Loss
Postmenopause
Drug: Isoflavones
Phase II

MedlinePlus related topics: Memory Menopause
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Phytoestrogens and Cognition in Menopause

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 96
Study Start Date: December 2002
Study Completion Date: August 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   62 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051402

Locations
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Krikorian, PhD University of Cincinnati
  More Information

Click here for more information about the study: Phytoestrogens and Cognition in Menopause. The Cognitive Disorders Center is directed by the principal investigator of this study.  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Postmenopausal
Memory Loss
Cognition
Phytoestrogens

Study placed in the following topic categories:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Neurobehavioral Manifestations
Memory Disorders
Menopause
Cognition Disorders
Amnesia
Delirium

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009