UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Acronym	A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Scientific Title	A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Scientific Title:Acronym	A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of intake of food including lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate abdominal visceral fat area and waist circumference when taking the test food continuously for 12 weeks
Key secondary outcomes	Evaluate body weight, BMI, total cholesterol, triacylglyceride, HDL-cholesterol, LDL-cholesterol, body fat percentage and muscle mass, abdominal CT (subcutaneous fat area, visceral fat area, psoas major muscle area), perimeter (neck, chest, arms, thighs, hips), subcutaneous fat thickness (chest, arms, thighs) when taking the test food continuously for 12 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food daily for 12 weeks
Interventions/Control_2	Intake of placebo daily for 12 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females from 20 to 64 years of age (2) Subjects whose BMI is 23 kg / m^2 or more and less than 30 kg / m^2. (3) The average blood pressure, triglycerides, HDL-cholesterol, and blood glucose of the entire intake initiator are considered to be within the reference range of each item
Key exclusion criteria	(1)Subjects who regularly ingest food, health food or medicine rich in lactic acid bacteria or natto bacteria (2)Subjects who are regularly ingest health food or medicine that affects body fat and lipid metabolism (3)Subjects who are judged to be unsuitable for research from the results of screening test pre-examination (4)Subjects who always use laxative when defecation (5)Subjects who have taken antibiotics within 3 months before fecal sampling (6)Subjects whose feces are unsuitable for research (7)Subjects who are judged to be unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function (8)Subjects who have been possibilities for emerging allergy related to the study (9)Subjects who are on a diet at the time of screening testpre-examination (10)Subjects who have diseases requiring regular administration, or who have severe diseases (11)Subjects who are judged to be unsuitable for the study based on the results of clinical laboratory test or physical examination (12)Subjects who are judged to be unsuitable for the study based on the results of lifestyle questionnaire (13)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (14)Subjects who plan to get pregnant or nurse a baby during this study (15)Subjects judged as unsuitable for the study by the investigator
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Kimiko Middle name Last name Uchiyama
Organization	KAMEDA SEIKA Co., Ltd.
Division name	Rice Research Institute
Zip code	950-0198
Address	3-1-1 Kameda-kogyodanchi, Konan-ku, Niigata-shi, Niigata
TEL	025-382-8879
Email	k_uchiyama@sk.kameda.co.jp

Public contact
Name of contact person	1st name Kyohei Middle name Last name Hashimoto
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.hashimoto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	KAMEDA SEIKA 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.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	2021 Year 11 Month 29 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	66
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	2020 Year 06 Month 25 Day
Date of IRB	2020 Year 06 Month 25 Day
Anticipated trial start date	2020 Year 07 Month 26 Day
Last follow-up date	2020 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 22 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047035