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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024337
Receipt No. R000027626
Scientific Title An exploratory study examining the effect of ONR-9 on fatigue in healthy adults: A randomized, double-blind, placebo-controlled, cross-over study.
Date of disclosure of the study information 2017/12/17
Last modified on 2017/04/10

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Basic information
Public title An exploratory study examining the effect of ONR-9 on fatigue in healthy adults: A randomized, double-blind, placebo-controlled, cross-over study.
Acronym the effect of the test food on fatigue
Scientific Title An exploratory study examining the effect of ONR-9 on fatigue in healthy adults: A randomized, double-blind, placebo-controlled, cross-over study.
Scientific Title:Acronym the effect of the test food on fatigue
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the test food on fatigue in healthy adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive task performance
Key secondary outcomes Mental task performance
Autonomic balance
Blood fatigue-related biomarkers
VAS (fatigue)
POMS
SF-36

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 Treatment
Type of intervention
Food
Interventions/Control_1 Intake of test food for a week, then intake of placebo for a week after 2-week wash out period.
Interventions/Control_2 Intake of placebo for a week, then intake of test food for a week after 2-week wash out period.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) healthy males and females
2) subjects who have normal breath gas response by oral administration of the test food.
Key exclusion criteria 1) subjects who have allergy to medicinal and foods.
2) subjects who have a severe past medical history, acute infection, or mental disorder.
3) subjects who will have stressful situation in the intake periods.
4) subjects who smoke more than 20 cigarettes a day.
5) subjects who take alcohol nearly every day.
6) subjects who take much caffeine rich drink.
7) shift wokers and graveyard shift.
8) subjects who routinely take medicin, supplements, FOSHU, and/or health food which affect to the result of the study.
9) subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address It's common number 4 number 13, Nihonbashikodenmacho, Chuo-ku, Tokyo, number 201 of building
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical 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
Address
Tel
Email

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
2017 Year 12 Month 17 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
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 07 Day
Last modified on
2017 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027626

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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