UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024337 |
|---|---|
| Receipt number | 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 11:35:32 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027626
| 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 |
