UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044852 |
|---|---|
| Receipt number | R000051230 |
| Scientific Title | Evaluation of the effect of the food product on daytime performance |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2024/01/16 08:52:22 |
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Basic information
Public title
Evaluation of the effect of the food product on daytime performance
Acronym
Evaluation of the effect of the food product on daytime performance
Scientific Title
Evaluation of the effect of the food product on daytime performance
Scientific Title:Acronym
Evaluation of the effect of the food product on daytime performance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the food product on daytime performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daytime performance (VAS questionnaires and electroencephalogram)
Key secondary outcomes
The relationship between daytime performance and stress response or sleep quality
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo intake for 4 weeks - Washout period for 4 weeks - Food product intake for 4 weeks
Interventions/Control_2
Food product intake for 4 weeks - Washout period for 4 weeks - Placebo intake for 4 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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults between the ages of 40 and 59
(2) Subjects who are aware of impaired sleep quality
Key exclusion criteria
(1) Subjects with skin disorders on the face or head
(2) Subjects have skin irritation due to application of 70 % ethanol
(3) Subjects who use an artificial cardiac pacemaker
(4) Subjects who are diagnosed with sleep disorders such as insomnia and sleep apnea syndrome
(5) Subjects who take sleep improving medications
(6) Smokers
(7) Subjects with milk or soy allergies
(8) Subjects with severe dry eye symptoms
(9) Subjects participating in other clinical trials during the study period
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Matsuda |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
TEL
042-577-8960
kazunori-matsuda@yakult.co.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Matsuda |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
TEL
042-577-8960
Homepage URL
kazunori-matsuda@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 13 | 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
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 27 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051230
