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Phytoestrogens and Memory Decline in Menopause

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00051402
First received: January 9, 2003
Last updated: October 24, 2007
Last verified: October 2007
History of Changes

January 9, 2003
October 24, 2007
December 2002
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Complete list of historical versions of study NCT00051402 on ClinicalTrials.gov Archive Site
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Phytoestrogens and Memory Decline in Menopause
Phytoestrogens and Cognition in Menopause

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Memory Loss
  • Postmenopause
Drug: Isoflavones
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
August 2007
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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
Female
62 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051402
R21 AT000567-01A1
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Robert Krikorian, PhD University of Cincinnati
National Center for Complementary and Alternative Medicine (NCCAM)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP