UMIN-CTR Clinical Trial

Basic information
Public title	Study of the effects of the food containing plant-derived ingredient on brain function and sleep
Acronym	Effects of plant-derived ingredient on brain function and sleep
Scientific Title	Study of the effects of the food containing plant-derived ingredient on brain function and sleep
Scientific Title:Acronym	Effects of plant-derived ingredient on brain function and sleep
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effects of plant-derived ingredient on brain function and sleep
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the brain function (cognitrax) and sleep quality (OSA Questionnaire, St. Mary's Hospital Sleep Questionnaire, sleep efficiency and nocturnal awakening time assessed by actigraph) before and after the 2-week treatment period.
Key secondary outcomes	Symptoms questionnaires, medical interview by physician, anthropometric measurements

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	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of active beverage (containing plant-derived ingredient) once a day for 2 weeks -> washout (2 weeks) -> Intake of placebo beverage (not containing plant-derived ingredient) once a day for 2 weeks.
Interventions/Control_2	Intake of placebo beverage (not containing plant-derived ingredient) once a day for 2 weeks -> washout (2 weeks) -> Intake of active beverage (containing plant-derived ingredient) once a day for 2 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	50 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	-healthy adult aged from 50 to 65 -Subjects who feeling sleep, or associated lowing function of their brain -Subjects who sleep more than five hours usually -Subjects who is not with disorders about sleep -Healthy subjects with not serious disorders -Subjects not difficult to deal with PC -Subjects with normal color sensation
Key exclusion criteria	-Subjects who have food allergy -Subjects who have metal allergy -Subjects who take a psychotropic medicine -Subjects who take a health food -non-smoking -Inadequate with physician's decision
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Ono Middle name Last name Takahiro
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL	03-6240-1162
Email	t.ono@ueno-asagao.clinic

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Address	Ueno Taito-ku Tokyo 110-0005, JAPAN
Tel	03-5816-0711
Email	i.takahashi@tes-h.co.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	うえのあさがおクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 21 Day

Related information
URL releasing protocol	Unpublished due to the protocol including the intellectual property rights
Publication of results	Unpublished

Result
URL related to results and publications	works in progress
Number of participants that the trial has enrolled	26
Results	A significant difference was observed in the primary outcome
Results date posted	2021 Year 01 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy adults
Participant flow	25 participants completed and 25 subjects were incorporated into the analyses
Adverse events	No adverse effect reported
Outcome measures	Cognitive function
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 30 Day
Date of IRB	2018 Year 07 Month 30 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry	2019 Year 01 Month 28 Day
Date trial data considered complete	2019 Year 02 Month 18 Day
Date analysis concluded	2019 Year 03 Month 19 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2021 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038568