UMIN-CTR Clinical Trial

Basic information
Public title	Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves(2)
Acronym	Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder(2)
Scientific Title	Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves(2)
Scientific Title:Acronym	Study on improvement of sleeping disorder by ingestion of mixed fermented tea leaf powder(2)
Region	Japan

Condition
Condition	sleeping disorder
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of ingention fermented tea leaf powder on the improvement of sleeping disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sleeping disorder
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects ingested the placebo meal for two weeks,and ingented the active meal for two weeks after two weeks.
Interventions/Control_2	The subjects ingested the active meal for two weeks,and ingented the active meal for two weeks after two weeks.
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Aged more than 20 (Healthy male and female between 20 and 70 years old) 2) Individuals who has subjective symptoms of sleeping disorder 3) Individuals who can refrain from over drinking and over eating during the test period 4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria	1)Subjects who are contracting or treating severe kidney and/or liver diseases 2)Individuals who have a chronic diseases and regularly use drugs 3)Those who can not stop taking a large amount of green tea or black tea during the test period 4)Pregnant women, or women with intending to become pregnant, and lactating woman 5)Individuals participating or intending to participate in a drug administration test 6)Individuals judged by the doctor to be unsuitable
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazunari Tanaka
Organization	Univercity of Nagasaki
Division name	Faculty of Nursing and Nutrition
Zip code
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	0958135216
Email	katanaka@sun.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hideki Ito
Organization	Univercity of Nagasaki
Division name	Regional Partnership Center
Zip code
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	0958135500
Homepage URL
Email	katanaka@sun.ac.jp

Sponsor
Institute	Univercity of Nagasaki
Institute
Department

Funding Source
Organization	Bio-oriented Technology Research Advancement Institution,NARO
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2018 Year 11 Month 22 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	2018 Year 11 Month 17 Day
Date of IRB	2018 Year 10 Month 30 Day
Anticipated trial start date	2018 Year 11 Month 17 Day
Last follow-up date	2019 Year 01 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	2018 Year 11 Month 08 Day
Last modified on	2019 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=R000039615