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NCT00051402 Clinical Trial

Phytoestrogens and Memory Decline in Menopause

Postmenopause Clinical Trial

Official title:
Phytoestrogens and Cognition in Menopause

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00051402
Other study ID # R21AT000567-01A1
Secondary ID
Status Completed
Phase Phase 2
First received January 9, 2003
Last updated October 24, 2007
Start date December 2002
Est. completion date August 2007

Study information
Verified date October 2007
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 62 Years and older
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Isoflavones

Locations
Country Name City State
United States University of Cincinnati College of Medicine Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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