UMIN-CTR Clinical Trial

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
Last 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
Email	keimizuno@riken.jp

Public contact
1st 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
Email	keimizuno@riken.jp

Sponsor
Institute	RIKEN Health Evaluation Team
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038406