UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015295
Receipt number R000017792
Scientific Title Research on foods for stress relief (2)
Date of disclosure of the study information 2014/10/06
Last modified on 2017/05/16 11:39:06

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Basic information

Public title

Research on foods for stress relief (2)

Acronym

Research on foods for stress relief (2)

Scientific Title

Research on foods for stress relief (2)

Scientific Title:Acronym

Research on foods for stress relief (2)

Region

Japan


Condition

Condition

Stress-related mental or physical disorders

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of fermented milk drinks on states of stress-related mental or physical disorders

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Effects of fermented milk drinks on stress-related sleep disorders

Key secondary outcomes

Effects of fermented milk drinks on stress-related abdominal symptoms


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 Lactobacillus casei strain Shirota for 8 weeks before Computer based testing (CBT) and 2 weeks after CBT

Interventions/Control_2

Daily intakes of placebo drinks without Lactobacillus casei strain Shirota for 8 weeks before CBT and 2 weeks after CBT

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 4th 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. Smokers.
4. Persons having allergy disease, including with dairy products.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhito Rokutan

Organization

The University of Tokushima Graduate School

Division name

Department of Stress Science, Institute of Health Bioscience

Zip code


Address

3-18-15 Kuramoto-cho, Kuramoto-city

TEL

088-633-9004

Email

stress.sci@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kensei Nishida

Organization

The University of Tokushima Graduate School

Division name

Department of Stress Science, Institute of Health Bioscience

Zip code


Address

3-18-15 Kuramoto-cho, Kuramoto-city

TEL

088-633-9004

Homepage URL


Email

knishida@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2014 Year 10 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

To investigate the effects of the probiotic Lactobacillus casei strain Shirota on abdominal dysfunction, a double-blind, placebo-controlled trial was conducted with healthy medical students undertaking an authorized nationwide examination for academic advancement.
1. Stress-induced increases in a visual analog scale measuring feelings of stress, the total score of abdominal dysfunction were significantly suppressed in the L. casei strain Shirota group compared with those in the placebo group.
2. A significant increase in salivary cortisol levels before the examination was observed only in the placebo group.
3. Stress-induced sleep disturbance was improved in the L. casei strain Shirota group.

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

Main results already published

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 14 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Neurogastroenterol Motil. 2016 Jul;28(7):1027-36. doi: 10.1111/nmo.12804.
Benef Microbes. 2017 Apr 26;8(2):153-162. doi: 10.3920/BM2016.0150.


Management information

Registered date

2014 Year 09 Month 30 Day

Last modified on

2017 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017792


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name