UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030856 |
|---|---|
| Receipt number | 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 22:39:25 |
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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
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
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035215
