UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033810 |
|---|---|
| Receipt number | 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 | 2021/01/08 23:23:03 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038568
