UMIN-CTR Clinical Trial

Public title

Research on foods for stress relief

Acronym

Research on foods for stress relief

Scientific Title

Research on foods for stress relief

Scientific Title:Acronym

Research on foods for stress relief

Region

Japan

Condition

Stress-related mental or physical disorders

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Effects of fermented milk drinks on stress-related abdominal symptoms

Key secondary outcomes

Effects of fermented milk drinks on mental stress relief

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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)

Interventions/Control_2

Daily intakes of placebo drinks without Lactobacillus casei strain Shirota for 8 weeks before 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

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

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

rokutan@tokushima-u.ac.jp

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

Institute

Tokushima University

Institute

Department

Personal name

Organization

Yakult Honsha Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

徳島大学

Date of disclosure of the study information

2013

Year

10

Month

07

Day

URL releasing protocol

Publication of results

Published

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. For 8 weeks, until the day before the examination, 23 and 24 subjects consumed an L. casei strain Shirota-fermented milk and a placebo milk daily, respectively. In addition to assessments of abdominal symptoms, psychophysical state, and salivary stress markers, gene expression changes in peripheral blood leukocytes and composition of the gut microbiota were analyzed using DNA microarray analysis and 16S rRNA gene amplicon sequence analysis, respectively, before and after the intervention. Stress-induced increases in a visual analog scale measuring feelings of stress, the total score of abdominal dysfunction, and the number of genes with changes in expression of more than 2-fold in leukocytes were significantly suppressed in the L. casei strain Shirota group compared with those in the placebo group. A significant increase in salivary cortisol levels before the examination was observed only in the placebo group. Moreover, 16S rRNA gene amplicon sequencing demonstrated that the L. casei strain Shirota group had significantly higher numbers of species, a marker of the alpha-diversity index.

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

Recruitment status

Main results already published

Date of protocol fixation

2013

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

18

Day

Last follow-up date

2014

Year

01

Month

30

Day

Date of closure to data entry

Date trial data considered complete

2014

Year

03

Month

14

Day

Date analysis concluded

Other related information

Appl Environ Microbiol. 82(12):3649-58. doi: 10.1128/AEM.04134-15.

Registered date

2013

Year

10

Month

01

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=R000013924