Phytoestrogens and Memory Decline in Menopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Memory Loss Postmenopause

Keywords

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Postmenopausal Memory Loss Cognition Phytoestrogens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Isoflavones

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

62 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Robert Krikorian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT000567-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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