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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018725
Receipt No. R000021193
Scientific Title Ameliorating effect of food product including Theanine and Casein peptide on sleep in postmenopausal women with complain of deteriorated sleep health : A randomized, double blind, placebo-controlled trial
Date of disclosure of the study information 2015/08/20
Last modified on 2017/03/14

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Basic information
Public title Ameliorating effect of food product including Theanine and Casein peptide on sleep in postmenopausal women with complain of deteriorated sleep health : A randomized, double blind, placebo-controlled trial
Acronym Effect of Theanine and Casein peptide on sleep: A randomized, double blind, placebo-controlled trial
Scientific Title Ameliorating effect of food product including Theanine and Casein peptide on sleep in postmenopausal women with complain of deteriorated sleep health : A randomized, double blind, placebo-controlled trial
Scientific Title:Acronym Effect of Theanine and Casein peptide on sleep: A randomized, double blind, placebo-controlled trial
Region
Japan

Condition
Condition Healthy individuals with relatively-deteriorated sleep health
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of food product containing Theanine and Casein peptide on sleep
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Autonomic nerve activity assessed by heart rate variability
Sleep variables assessed by actigraphy at before, 1-week, 2-week, 4-week consumption.
Key secondary outcomes Sleep quality assessed by subjective rating scales at before, 1-week, 2-week, 4-week consumption.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The food containing Theanine(200 mg) and Casein peptide (150 mg)
Treatment duration: one month.
Interventions/Control_2 Placebo
Treatment duration: one month.
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
50 years-old <=
Age-upper limit
69 years-old >
Gender Female
Key inclusion criteria Healthy postmenopausal women with relatively-deteriorated sleep health screened by sleep habits questionnaire and Pittsburgh sleep quality index (PSQI)
Key exclusion criteria Patients having medical symptoms leading to sleep disturbance seriously
Individuals considered medically inappropriate attend to the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Matsuura
Organization S&A Associates, Inc.
Division name S&A Associates, Inc.
Zip code
Address 2-18-4, Chuo-ku Nihombashi, Tokyo
TEL 03-3249-7510
Email matsuura@s-a-associates.com

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Matsuura
Organization S&A Associates, Inc.
Division name S&A Associates, Inc.
Zip code
Address 2-18-4, Chuo-ku Nihonbashi, Tokyo
TEL 03-3249-7510
Homepage URL
Email matsuura@s-a-associates.com

Sponsor
Institute S&A Associates, Inc.
Institute
Department

Funding Source
Organization Bean Stalk Snow Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 08 Month 20 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 Terminated
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 19 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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