UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of intake of test food on mood states
Acronym	A study for the effect of intake of test food on mood states
Scientific Title	A study for the effect of intake of test food on mood states
Scientific Title:Acronym	A study for the effect of intake of test food on mood states
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of test food on mood states
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mood states
Key secondary outcomes	Subjective cognitive function Questionnaires

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1) Without intake of test drink, 1 week 2) Intake of test drink (350 mL/day), 3 weeks
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who fall under all of the following (1) to (3) (1) Healthy men and women over the age of 20 when consent is obtained (2) Those whose primary language is Japanese (3) Those with mental fatigue
Key exclusion criteria	(1) Those who cannot consent to participate in the study in writing (2) Those who have allergy to test foods (3) Those who are under treatment of cranial nerve disease (4) Those who have anamnesis of cranial nerve disease (5) Those who and whose family is working in Kirin Holdings Company, Limited or its group companies
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kuniaki Middle name Last name Obara
Organization	Kirin Holdings Company, Limited
Division name	Research and Development division, Kirin Central Research Institute
Zip code	236-0004
Address	1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	080-1930-9932
Email	k-obara@kirin.co.jp

Public contact
Name of contact person	1st name Takafumi Middle name Last name Fukuda
Organization	Kirin Holdings Company, Limited
Division name	Research and Development division, Kirin Central Research Institute
Zip code	236-0004
Address	1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	080-1930-9968
Homepage URL
Email	Takafumi_Fukuda@kirin.co.jp

Sponsor
Institute	Kirin Holdings Company, Limited
Institute
Department

Funding Source
Organization	Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mitsui Fudosan Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Human Research Ethics Committee, Kirin Group
Address	4-10-2, Nakano, Nakano-ku, Tokyo
Tel	03-6837-4128
Email	02976_Ni@kirin.co.jp

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	2021 Year 06 Month 30 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	Main results already published
Date of protocol fixation	2020 Year 06 Month 18 Day
Date of IRB	2020 Year 06 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 05 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 15 Day
Last modified on	2022 Year 01 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046935