Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women

Soy Isoflavone Tablets: Effects on Questionnaire and Actigraphic Measures of Sleep, Symptoms as Measured by the Women's Health Questionnaire and Cognitive Function as Measured by Computerized Cognitive Performance Tests in Menopausal Women

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01401946

Enrollment

Registered

2011-07-26

Start date

2000-05-31

Completion date

2001-01-31

Last updated

2011-07-26

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

Conditions

Hot Flashes

Brief summary

The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.

Interventions

DRUGsoy isoflavones

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* At least 5 hot flash episodes and/or night sweats per 24 hours

Exclusion criteria

* Body mass index (BMI) more than 34 kg/m2 * Hypertension * Shift work * Psychiatric or medical conditions that would affect outcome measures * More than 4 caffeine drinks per day * More than 10 cigarettes per day * More than than 7 alcohol drinks per week

Design outcomes

Primary

Measure	Time frame	Description
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women	Nine weeks	Hot flashes recorded by means of 5 global estimation and daily diary measures of hot flashes and night sweats.
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women	9 weeks	Subjective sleep measured by average questionnaire item scores recorded each morning for a week, repeated at baseline and 4 subsequent times

Countries

United States

Outcome results

None listed

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