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

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 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


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

Value
https://center6.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