UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019113
Receipt number R000022096
Scientific Title Effects of soy milk on insomnia in middle-aged women
Date of disclosure of the study information 2015/09/25
Last modified on 2023/04/01 11:46:33

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Basic information

Public title

Effects of soy milk on insomnia in middle-aged women

Acronym

Effects of soy milk on insomnia in middle-aged women

Scientific Title

Effects of soy milk on insomnia in middle-aged women

Scientific Title:Acronym

Effects of soy milk on insomnia in middle-aged women

Region

Japan


Condition

Condition

menopausal symptoms
insomnia

Classification by specialty

Obstetrics and Gynecology Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of soy milk on subjective and objective sleep parameters in middle-aged women with insomnia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

St. Mary's Hospital Sleep Questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and actigraphy, after 8 weeks of treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

8-week treatment with 800 mL/day of soy milk

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

women with subjective insomnia scoring 6 or more on the Athens Insomnia Scale

Key exclusion criteria

women who are treated with estrogens, Kampo medicine, psychotropic agents etc.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masakazu
Middle name
Last name Terauchi

Organization

Masakazu Terauchi

Division name

Department of Women's Health

Zip code

1138510

Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-4605

Email

teragyne@tmd.ac.jp


Public contact

Name of contact person

1st name Masakazu
Middle name
Last name Terauchi

Organization

Tokyo Medical and Dental University

Division name

Department of Women's Health

Zip code

1138510

Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-4605

Homepage URL


Email

teragyne@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

Yushima 1-5-45, Bunkyo, Tokyo

Tel

03-3813-6111

Email

info.bec@tmd.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 09 Month 15 Day

Date of IRB

2015 Year 08 Month 17 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 09 Month 25 Day

Last modified on

2023 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name