UMIN-CTR Clinical Trial

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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