UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033686 |
|---|---|
| Receipt number | R000038406 |
| Scientific Title | Investigation for the anti-fatigue effects of ingestion of drinks in workers |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/04/26 13:55:48 |
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Basic information
Public title
Investigation for the anti-fatigue effects of ingestion of drinks in workers
Acronym
Anti-fatigue effects of drinks
Scientific Title
Investigation for the anti-fatigue effects of ingestion of drinks in workers
Scientific Title:Acronym
Anti-fatigue effects of drinks
Region
| Japan |
Condition
Condition
Healthy Person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Investigation for the anti-fatigue effects of ingestion of drinks in workers
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 before and after the 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy persons who are aged from 20 to 49 years.
2. Persons who are full-time worker on the day shift.
3. Persons who can give written informed consents.
Key exclusion criteria
1. Persons who have previous history such as neurological disorder, nervous system disorder, cardiovascular disease, and other serious disease.
2. Persons who have previous history of nervous system disease such as unconsciousness, coma, convulsion, etc.
3. Persons who are in treatment.
4. Persons who usually take in health foods and supplements.
5. Persons who have food allergy.
6. Persons who have vision disorder or auditory disorder.
7. Persons who are pregnant or breastfeed.
8. Persons who can't drink soda.
9. Persons who had ever felt sick during a blood test.
10. Persons who are now participating in other clinical trials, or participated in other clinical trials within a month before obtaining his/her informed consent in this trial.
11. Persons who are judged not suitable to participate in this trial by investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
RIKEN
Division name
Health Evaluation Team
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
Division name
Health Evaluation Team
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 Health Evaluation Team
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（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2019 | 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
29
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 | 04 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038406
