UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2019 Year 05 Month 31 Day
Date of IRB	2019 Year 06 Month 03 Day
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	2021 Year 06 Month 08 Day

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