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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028823
Receipt No. 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

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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
Email 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
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032989

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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