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

Phase 4

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Placebo; Drug: soy isoflavones

• Registration Number: NCT01401946
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2000-10
• Study Completion: 2001-01
• Study First Submitted: 2010-12-08
• Status Verified: 2011-07
• Study First Submitted QC: 2011-07-25
• Last Update Submitted: 2011-07-25
• Study First Posted: 2011-07-26
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
soy isoflavones	soy isoflavones	-

Primary Outcome Measures

Name	Time	Method
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women	9 weeks	Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women	9 weeks	Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions

Trial Locations

Locations (1)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States