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Phytoestrogens and Memory Decline in Menopause

Phytoestrogens and Cognition in Menopause

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00051402
Enrollment
96
Registered
2003-01-15
Start date
2002-12-31
Completion date
2007-08-31
Last updated
2007-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Loss, Postmenopause

Keywords

Postmenopausal, Memory Loss, Cognition, Phytoestrogens

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.

Interventions

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
62 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026