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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036941
Receipt No. R000042095
Scientific Title The effect of Lactobacillus on mood states in summer: a randomized, double-blind, placebo-controlled study.
Date of disclosure of the study information 2020/01/31
Last modified on 2019/06/03

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Basic information
Public title The effect of Lactobacillus on mood states in summer: a randomized, double-blind, placebo-controlled study.
Acronym The effect of Lactobacillus on mood states in summer
Scientific Title The effect of Lactobacillus on mood states in summer: a randomized, double-blind, placebo-controlled study.
Scientific Title:Acronym The effect of Lactobacillus on mood states in summer
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of ingestion of Lactobacillus on mood states of healthy adults in summer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Profile of Mood States Second Edition-adult Short
Key secondary outcomes Visual Analogue Scale
Chalder Fatigue Scale
Simplified Nutritional Appetite

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of Lactobacillus for 13 weeks
Interventions/Control_2 Ingestion of placebo for 13 weeks
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
65 years-old >
Gender Male and Female
Key inclusion criteria Subjects between 20 to 64 years old
Key exclusion criteria 1) Subjects with regular use of medicine due to chronic diseases
2) Subjects who consume supplements or food habitually containing Lactobacillus, Bifidobacterium, GABA, theanine and caffeine, etc.
3) Subjects with milk allergy
4) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
5) Subjects in pregnancy or breast-feeding
6) Subjects who are judged inappropriate to this trial by the investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Kurokawa
Organization Kyushu University of Health and Welfare
Division name Department of Biochemistry, Graduate School of Clinical Pharmacy
Zip code 882-8508
Address 1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
TEL 0982-23-5574
Email b2mk@phoenix.ac.jp

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Kurokawa
Organization Kyushu University of Health and Welfare
Division name Department of Biochemistry, Graduate School of Clinical Pharmacy
Zip code 882-8508
Address 1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
TEL 0982-23-5574
Homepage URL
Email b2mk@phoenix.ac.jp

Sponsor
Institute Department of Biochemistry, Graduate School of Clinical Pharmacy, Kyushu University of Health and Welfare
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co., 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 Institutional Review Board at Kyushu University of Health and Welfare
Address 1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
Tel 0982-23-5574
Email b2mk@phoenix.ac.jp

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 九州保健福祉大学

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 31 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 17 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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