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
  Purpose

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 Intervention Phase
Memory Loss
Postmenopause
Drug: Isoflavones
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phytoestrogens and Cognition in Menopause

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 96
Study Start Date: December 2002
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   62 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051402

Locations
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Krikorian, PhD University of Cincinnati
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00051402     History of Changes
Other Study ID Numbers: R21 AT000567-01A1
Study First Received: January 9, 2003
Last Updated: October 24, 2007
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Postmenopausal
Memory Loss
Cognition
Phytoestrogens

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

ClinicalTrials.gov processed this record on July 31, 2014