UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028823 |
|---|---|
| Receipt number | R000032989 |
| Scientific Title | Effect on concentration (and cognitive function) by single ingestion of a test food |
| Date of disclosure of the study information | 2017/09/26 |
| Last modified on | 2018/03/01 08:33:19 |
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Basic information
Public title
Effect on concentration (and cognitive function) by single ingestion of a test food
Acronym
Effect on concentration (and cognitive function) by single ingestion of a test food
Scientific Title
Effect on concentration (and cognitive function) by single ingestion of a test food
Scientific Title:Acronym
Effect on concentration (and cognitive function) by single ingestion of a test food
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of a test food on concentration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Cognitrax 2.Uchida-Kraepelin Test
Key secondary outcomes
1.POMS2 (Brief edition) 2.VAS
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
On the day intake of the test food
Wash out
On the day intake of the placebo
Interventions/Control_2
On the day intake of the placebo
Wash out
On the day intake of the test food
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects giving written informed consent.
2.Japanese males and females aged 30-59 years.
3.Non-smokers.
Key exclusion criteria
1.Subjects currently in treatment with medication or seeing a doctor for treatment.
2. Subjects having a history of a drug allergy and/or food allergy.
3.Subjects being pregnant or nursing, or desired to become pregnant during the study.
4.Subjects being patient or having a history of severe brain disorder.
5.Subjects being vaccinated within the last three months or desired to be vaccinated during a study period.
6.Subjects having regular intake of a health foods or supplements with a possible effect on improved concentration.
7.Subjects being patient or having a history of psychiatric visits for depression, sleep disorder, etc.
8.Subjects having extremely irregular lifestyle such as a dietary pattern and a sleeping pattern.
9.Subjects participated in another clinical trial in the last three months.
10.Subjects determined by the investigator to be unsuitable for enrollment in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings,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 | 09 | Month | 26 | 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
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 27 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032989
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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