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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401946
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  Purpose
The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.

Condition Intervention Phase
Hot Flashes Drug: soy isoflavones Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women [ Time Frame: Nine weeks ]
    Hot flashes recorded by means of 5 global estimation and daily diary measures of hot flashes and night sweats.

  • Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women [ Time Frame: 9 weeks ]
    Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions

  • Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women [ Time Frame: 9 weeks ]
    Subjective sleep measured by average questionnaire item scores recorded each morning for a week, repeated at baseline and 4 subsequent times

  • Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women [ Time Frame: 9 weeks ]
    Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.


Enrollment: 88
Study Start Date: May 2000
Study Completion Date: January 2001
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: soy isoflavones Drug: soy isoflavones
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401946


Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

Responsible Party: Quentin R. Regestein, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT01401946     History of Changes
Other Study ID Numbers: 99-004-P
First Submitted: December 8, 2010
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms