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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046666
Receipt No. R000053238
Scientific Title A study of the effect of food ingredient on brain function and mood (SIC-2021-04-SHKBSE)
Date of disclosure of the study information 2022/01/18
Last modified on 2022/01/18

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Basic information
Public title A study of the effect of food ingredient on brain function and mood (SIC-2021-04-SHKBSE)
Acronym A study of the effect of food ingredient on brain function and mood (SIC-2021-04-SHKBSE)
Scientific Title A study of the effect of food ingredient on brain function and mood (SIC-2021-04-SHKBSE)
Scientific Title:Acronym A study of the effect of food ingredient on brain function and mood (SIC-2021-04-SHKBSE)
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effect of food ingredients on brain function and mood..
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax
Key secondary outcomes

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 Subjects will take the food (1) once a day after fatigue loading. After more than 4 weeks of washout period, subjects will take the food (2) once a day after fatigue loading.
Interventions/Control_2 Subjects will take the food (2) once a day after fatigue loading. After more than 4 weeks of washout period, subjects will take the food (1) once a day after fatigue loading.
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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Subjects who can make self-judgment and are voluntarily giving written informed consent.
(2) From 40 to 65 years healthy men and women.
(3) Subject who are can visit the designated facility on measurement days.
Key exclusion criteria (1)Subjects who have a history or are suspected patient of psychiatric disorders.
(2)Subjects who have major surgical history relevant to the digestive system such as gastrectomy, gastrointestinal suture, or intestinal resection.
(3)Subjects who are with systolic blood pressure of less than 90 mmHg.
(4)Subjects who have unusually high and/or low blood pressure and/or abnormal hematological data.
(5)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Watanabe
Organization Suntory global innovation center limited.
Division name Research Institute
Zip code 619-0284
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL 050-3182-0593
Email H_Watanabe@suntory.co.jp

Public contact
Name of contact person
1st name Mariko
Middle name
Last name Sato
Organization Suntory global innovation center limited.
Division name Research Institute
Zip code 619-0284
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL 050-3182-0954
Homepage URL
Email Mariko_Sato@suntory.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Suntory global innovation center limited.
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 the ethics committees of Yoga Allergy Clinic
Address 4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
Tel 03-5491-4478
Email info@yg-allergy.com

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 01 Month 18 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 40
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
2021 Year 08 Month 13 Day
Date of IRB
2021 Year 08 Month 13 Day
Anticipated trial start date
2021 Year 09 Month 21 Day
Last follow-up date
2022 Year 01 Month 07 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 01 Month 18 Day
Last modified on
2022 Year 01 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053238

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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