UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041111
Receipt No. R000046935
Scientific Title A study for the effect of intake of test food on mood states
Date of disclosure of the study information 2021/06/30
Last modified on 2021/07/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 No longer recruiting
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
2021 Year 07 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.