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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033570
Receipt No. R000038268
Scientific Title Effect on concentration (and cognitive function) by single ingestion of a test food
Date of disclosure of the study information 2018/08/20
Last modified on 2019/01/17

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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 The objective of this study was to investigate the effect of a single dose of the test food on concentration in healthy Japanese men and women aged 30 years or older and younger than 50 years.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax,Uchida Kraepelin test
Key secondary outcomes POMS2 shorter version,VAS questionnaire,Salivary marker

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
50 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese men and women aged 30 to younger than 50 at the time of informed consent
2)Non smoker
3)A person who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria 1)Patients currently receiving any type of drug or outpatient treatment
2)Subjects who are currently receiving exercise or dietary therapy under the supervision of a physician.
3)Persons with a history or current or concurrent liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
4)Patients with a history of drug or food allergy
5)Those who wish to do so during pregnancy, lactation, or the duration of the study.
6)Persons with serious or past brain diseases.
7)Subjects who have received blood donations or vaccinations within the previous 3 months or have scheduled them during the study period.
8)People who routinely consume health foods, supplements, and medicines that may affect concentration
9)Persons with a history of psychiatric disorders (e.g., depression), sleep disorders, or psychiatric disorders in the past.
10)Alcoholism, substance abuse, or substance abuse with treatment or a history of treatment.
11)Employees working during night shifts, etc.
12)Excessively irregular lifestyle such as eating or sleeping
13)Subjects who have participated in other clinical studies or have participated in other clinical studies within the previous 3 months.
14)Persons who are difficult to comply with the records of various surveys
15)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size 80

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 Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Email ochitani@huma-rd.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 Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-rd.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 Japan

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
2018 Year 08 Month 20 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
2018 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
2018 Year 10 Month 20 Day
Date of closure to data entry
2018 Year 10 Month 29 Day
Date trial data considered complete
2018 Year 10 Month 29 Day
Date analysis concluded
2018 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 31 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038268

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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