UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033570 |
|---|---|
| Receipt number | 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 16:26:23 |
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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
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
ochitani@huma-rd.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
Japan
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038268
