UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018725 |
|---|---|
| Receipt number | 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 11:13:13 |
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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
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
matsuura@s-a-associates.com
Sponsor or person
Institute
S&A Associates, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021193
