UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018491
Receipt number R000021373
Scientific Title research on fermented milk for stress relief
Date of disclosure of the study information 2015/10/15
Last modified on 2016/09/12 12:07:49

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Basic information

Public title

research on fermented milk for stress relief

Acronym

research on fermented milk for stress relief

Scientific Title

research on fermented milk for stress relief

Scientific Title:Acronym

research on fermented milk for stress relief

Region

Japan


Condition

Condition

healthy adults who feel stress

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of LAB-ingestion on mental and physical conditions under chronic stress

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate effects of LAB-ingestion on mental and physical conditions at 6 and 12 weeks into intervention by Stress-related Questionnaire and measurement items

Key secondary outcomes

Sleep Quality-related Questionnaire and measurement Items


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Daily intakes of fermented milk drinks including gasseri strain for 14 weeks before the National Medical Practitioners Qualifying Examination

Interventions/Control_2

Daily intakes of fermented milk drinks without gasseri strain for 14 weeks before the National Medical Practitioners Qualifying Examination

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

Subjects are 6th grade medical students who are in good physical health.

Key exclusion criteria

1. Persons having history of psychiatric or somatic diseases in the past and present.
2. Persons taking medication at least for three months prior to the enrollment and during the experimental period.
3. Persons having milk and soy bean allergies.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhito Rokutan

Organization

Tokushima University

Division name

Dept. of Pathophysiology, Inst. of Biomedical Sciences

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima

TEL

088-633-9004

Email

rokutan@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kensei Nishida

Organization

Tokushima University

Division name

Dept. of Pathophysiology, Inst. of Biomedical Sciences

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima

TEL

099-633-9004

Homepage URL


Email

knishida@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

Asahi Group Holdings, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

2015 Year 10 Month 15 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

2015 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 30 Day

Last modified on

2016 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name