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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033810
Receipt No. R000038568
Scientific Title Study of the effects of the food containing plant-derived ingredient on brain function and sleep
Date of disclosure of the study information 2018/08/21
Last modified on 2019/08/19

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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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 26
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 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
2019 Year 08 Month 19 Day


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

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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