UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026125 |
|---|---|
| Receipt number | R000030020 |
| Scientific Title | Investigation of the anti-fatigue effects of drinks in children and adolescents. |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/04/05 15:47:28 |
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Basic information
Public title
Investigation of the anti-fatigue effects of drinks in children and adolescents.
Acronym
The anti-fatigue effects of drinks.
Scientific Title
Investigation of the anti-fatigue effects of drinks in children and adolescents.
Scientific Title:Acronym
The anti-fatigue effects of drinks.
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-fatigue effects of drinks in children and adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in autonomic nerve function and cognitive function after administration.
Key secondary outcomes
Subjective fatigue
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Administration of 150 ml of test drink. / Administration of 150 ml of placebo drink1. / Administration of 150 ml of placebo drink2.
Interventions/Control_2
Administration of 150 ml of placebo drink1. / Administration of 150 ml of placebo drink2. / Administration of 150 mil of test drink.
Interventions/Control_3
Administration of 150 ml of placebo drink2. / Administration of 150 ml of test drink. / Administration of 150 ml of placebo drink1.
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children and adolescents from the 4th grade to 9th grade.
Key exclusion criteria
Subject who are judged not suitable to participate in this study by investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
RIKEN Center for Biosystems Dynamics Research
Division name
Laboratory for Pathophysiological and Health Science
Zip code
650-0047
Address
6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL
078-569-8868
keimizuno@riken.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
RIKEN Center for Biosystems Dynamics Research
Division name
Laboratory for Pathophysiological and Health Science
Zip code
650-0047
Address
6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL
078-569-8868
Homepage URL
keimizuno@riken.jp
Sponsor or person
Institute
RIKEN Center for Biosystems Dynamics Research
Institute
Department
Personal name
Funding Source
Organization
ASAHI SOFT DRINKS CO., LTD.
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
RIKEN
Address
2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
Tel
078-306-3036
kobe-ankan@cdb.riken.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
国立研究開発法人理化学研究所 生命機能科学研究センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 31 | 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
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2017 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
