Phytoestrogens and Memory Decline in Menopause
Primary Purpose
Memory Loss, Postmenopause
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Isoflavones
Sponsored by
About this trial
This is an interventional treatment trial for Memory Loss focused on measuring Postmenopausal, Memory Loss, Cognition, Phytoestrogens
Eligibility 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
Sites / Locations
- University of Cincinnati College of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00051402
First Posted
January 9, 2003
Last Updated
October 24, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00051402
Brief Title
Phytoestrogens and Memory Decline in Menopause
Official Title
Phytoestrogens and Cognition in Menopause
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Loss, Postmenopause
Keywords
Postmenopausal, Memory Loss, Cognition, Phytoestrogens
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
96 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Isoflavones
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Krikorian, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.psychiatry.uc.edu/cdc/index.asp?pid=64
Description
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.
Learn more about this trial
Phytoestrogens and Memory Decline in Menopause
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