Viewing Study NCT00051402



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Study NCT ID: NCT00051402
Status: COMPLETED
Last Update Posted: 2007-10-26
First Post: 2003-01-09

Brief Title: Phytoestrogens and Memory Decline in Menopause
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Phytoestrogens and Cognition in Menopause
Status: COMPLETED
Status Verified Date: 2007-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None