UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of LAB (heat-killed) on Visceral Fat.
Acronym	A study on the effect of LAB (heat-killed) on Visceral Fat.
Scientific Title	A study on the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat.
Scientific Title:Acronym	A study on the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat.
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Lactobacillus brevis KB290 (heat-killed) on Visceral Fat reduction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Abdominal subcutaneous fat area, total fat area, body weight (BMI), blood pressure, body fat percentage, muscle mass, waist/hip circumference, AST (GOT), ALT (GPT), gamma-GTP, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, blood glucose level, insulin, HbA1c, HOMA-IR, fecal microbiota.

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
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A beverage not containing heat-killed Labre per day for 12 weeks.
Interventions/Control_2	A beverage containing heat-killed Labre (low-dose) per day for 12 weeks.
Interventions/Control_3	A beverage containing heat-killed Labre (high-dose) per day for 12 weeks.
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	(1)Japanese male and female aged 20 to 64 years-old at acquisition of the consent. (2)Whose BMI are 23 or more and less than 30 at screening test. (3)Who can make self-judgment, voluntarily agreed to participate to this study, and provide written informed consent.
Key exclusion criteria	(1)Who use medicines that may affect obesity, hyperlipidemia, lipid metabolism. (2)Who has such serious diseases as liver disease, cardiovascular disease, respiratory disease, endocrine disorder, metabolic disease, food allergy disease. (3)Who cannot stop intake health foods or supplements which may affect obesity, hyperlipidemia, lipid metabolism, during this study. (4)Who has a current or history of drug dependence and/or alcoholism. (5)Who has been implanted metal in the DUAL SCAN measurement site. (6)Who has implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator). (7)Who has been diagnosed as familial hyperlipidemia. (8)Who is pregnant or breast-feeding or willing to be pregnant during this study. (9)Who has an irregular diet, and/or is shift worker and/or midnight-shift worker. (10)Who is planning to participate and/or has participated in other clinical studies. (11)Who is judged as unsuitable for this study by the principal investigator.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name Suzuki
Organization	Kagome Co., Ltd.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0014
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	Kagome Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	KSO Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagome Ethics Committee
Address	3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel	03-5623-8501
Email	Takuji_Hayakawa@kagome.co.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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 24 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 07 Month 18 Day
Date of IRB	2019 Year 07 Month 19 Day
Anticipated trial start date	2019 Year 08 Month 24 Day
Last follow-up date	2019 Year 12 Month 08 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 08 Month 07 Day
Last modified on	2020 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042891