UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Noriko Matsuura
Organization	S&A Associates, Inc.
Division name	S&A Associates, Inc.
Address	2-18-4, Chuo-ku Nihombashi, Tokyo
TEL	03-3249-7510
Email	matsuura@s-a-associates.com

Public contact
Name of contact person	Noriko Matsuura
Organization	S&A Associates, Inc.
Division name	S&A Associates, Inc.
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021193