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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030856
Receipt No. R000035215
Scientific Title Investigation of anti-stress effect associated with ingestion of pickled sun-dried daikon radish ~A randomization single-blind, placebo-controlled study
Date of disclosure of the study information 2018/01/17
Last modified on 2019/03/06

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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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