UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of anti-stress effect associated with ingestion of pickled sun-dried daikon radish ~A randomization single-blind, placebo-controlled study
Acronym	The trial for investigation of anti-stress effect associated with ingestion of pickled sun-dried daikon radish
Scientific Title	Investigation of anti-stress effect associated with ingestion of pickled sun-dried daikon radish ~A randomization single-blind, placebo-controlled study
Scientific Title:Acronym	The trial for investigation of anti-stress effect associated with ingestion of pickled sun-dried daikon radish
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the anti-stress effect associated with ingestion of pickled sun-dried daikon radish.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mood profile test (POMS)
Key secondary outcomes	1.VAS scale 2.Change of workload on the Uchida-Kraepelin test 3.Activity of saliva amylase 4.Adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects take 50g test food (pickled sun-dried daikon radish) before stress workload.
Interventions/Control_2	The subjects take 50g placebo food (not containing GABA pickled sun-dried daikon radish) before stress workload.
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	29 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria	1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire. 2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 3. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 4. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency 5. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 6. Pregnant or lactating women or women expect to be pregnant during this study. 7. Subjects who have cognitive disorder or who have possibility of the disorder. 8. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 9. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Homepage URL
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	Miyazaki Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 17 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 01 Month 03 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 24 Day
Last follow-up date	2018 Year 02 Month 21 Day
Date of closure to data entry	2018 Year 03 Month 08 Day
Date trial data considered complete	2018 Year 03 Month 13 Day
Date analysis concluded	2019 Year 03 Month 06 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 17 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035215

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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