UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049784 |
|---|---|
| Receipt number | R000056556 |
| Scientific Title | Study on the effect of supplements on concentration |
| Date of disclosure of the study information | 2022/12/15 |
| Last modified on | 2023/06/14 09:49:16 |
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Basic information
Public title
Study on the effect of supplements on concentration
Acronym
Study on the effect of supplements on concentration
Scientific Title
Study on the effect of supplements on concentration
Scientific Title:Acronym
Study on the effect of supplements on concentration
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study on the effects of supplementation on concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Trail Making Test
Key secondary outcomes
The Uchida-Kraepelin test
Autonomic nerve function
Subjective fatigue
OSA sleep inventory MA version
Game results
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Duration:28 days
Intake of test food
Interventions/Control_2
Duration:28 days
Intake of placebo
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy students aged 18 and over.
2) Individuals giving the written informed consent.
Key exclusion criteria
1)Subjects who have food allergy to soybeans
2)Subjects who are taking medicines and health foods related to fatigue, stress and sleep.
3)Subjects who cannot stop drinking alcohol on the day before the experimental day and on the experimental day, drinking excessive amounts of alcohol during the experimental days and consuming caffeine or energy drinks on the experimental day.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirohisa |
| Middle name | |
| Last name | Isogai |
Organization
Kyushu Sangyo University
Division name
Human Science
Zip code
813-0004
Address
2-3-1 Matsukadai, Higashi-ku, Fukuoka City, Fukuoka Prefecture
TEL
090-9495-5291
isogai@ip.kyusan-u.ac.jp
Public contact
Name of contact person
| 1st name | Saito |
| Middle name | |
| Last name | Yoshiko |
Organization
Behavior Assessment System Laboratory
Division name
Director Researcher
Zip code
815-0032
Address
1-28-23 Shiobaru, Minami-ku, Fukuoka City, Fukuoka Prefecture
TEL
090-4353-9416
Homepage URL
saitou@baslab.or.jp
Sponsor or person
Institute
Behavior Assessment System Laboratory
Institute
Department
Personal name
Funding Source
Organization
NOF CORPORATION
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
Kyusyu Sangyo University ethics committee
Address
2-3-1 Matsukadai, Higashi-ku, Hukuoka City, Fukuoka Prefecture
Tel
092-673-5489
renkei@ip.kyusan-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 15 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056556
| 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 |
