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Phytoestrogens and Memory Decline in Menopause

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ClinicalTrials.gov Identifier: NCT00051402
Recruitment Status : Completed
First Posted : January 15, 2003
Last Update Posted : October 26, 2007
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Memory Loss Postmenopause Drug: Isoflavones Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phytoestrogens and Cognition in Menopause
Study Start Date : December 2002
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Menopause
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   62 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051402


Locations
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Robert Krikorian, PhD University of Cincinnati

Additional Information:
ClinicalTrials.gov Identifier: NCT00051402     History of Changes
Other Study ID Numbers: R21AT000567-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2003    Key Record Dates
Last Update Posted: October 26, 2007
Last Verified: October 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Postmenopausal
Memory Loss
Cognition
Phytoestrogens

Additional relevant MeSH terms:
Physiological Effects of Drugs
Memory Disorders
Amnesia
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists