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OpenTrials
Completed

NCT Number: NCT00051402

Phytoestrogens and Memory Decline 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.

Completed

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Key information

Age range

62 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267-0559, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoflavones

Drug

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

Phytoestrogens and Cognition in Menopause

Important dates

Study start
2002
Study completion
2007
First posted
Jan 15, 2003
Registry last updated
Oct 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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