UMIN-CTR Clinical Trial

Basic information
Public title	Study on effects of long-tern ingestion of beverages containing lactic acid bacterium producing substance on body fat.
Acronym	Effects of beverages containing lactic acid bacterium producing substance on body fat.
Scientific Title	Study on effects of long-tern ingestion of beverages containing lactic acid bacterium producing substance on body fat.
Scientific Title:Acronym	Effects of beverages containing lactic acid bacterium producing substance on body fat.
Region	Japan

Condition
Condition	obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of long-tern ingestion of beverages containing lactic acid bacterium producing substance on suppression of body fat.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Body weight, Body fat percentage, BMI, Waist length, Blood pressure, Serum cholesterol, Serum triglyceride, Blood glucose level, GOT, GPT, Gamma-GTP, White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, LD, Total bilirubin, ALP, HbA1c, Total protein, Albumin, Urea nitrogen, Creatinine, Uric acid

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The subjects ingested the placebo meal for eight weeks
Interventions/Control_2	The subjects ingested the active meal for eight 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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy male and female between 20 and 80 years old 2) Visceral fat area 80 cm2 or more, body mass index between 23 and 30 3) Individuals who can refrain from over drinking and over eating during the test period 4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria	1)Individuals taking drugs affect lipid metabolism 2)Those who can not stop taking supplements or health foods that may affect lipid metabolism during the test period 3)Subjects who are contracting or treating severe diabetes and kidney and/or liver diseases 4)Those who have been diagnosed with familial hyperlipidemia 5)Individuals with a chronic diseases 6)Those who can not stop taking a large amount of lactic acid bacteria beverage during the test period 7)Pregnant women, or women with intending to become pregnant, and lactating woman 8)Individuals participating or intending to participate in other drug administration tests 9)Individuals judged by the doctor to be unsuitable
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kaunari Middle name Last name Tanaka
Organization	Univercity of Nagasaki
Division name	Faculty of Nursing and Nutrition
Zip code	851-2195
Address	1-1-1 Manabino, Nagayo-cho, Nishisosnogi-gun, Nagasaki, Japan,
TEL	0958135216
Email	katanaka@sun.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Ito
Organization	Univercity of Nagasaki
Division name	Regional Partnership Center
Zip code	851-2195
Address	1-1-1 Manabino, Nagayo-cho, Nishisosnogi-gun, Nagasaki, Japan
TEL	0958135216
Homepage URL
Email	katanaka@sun.ac.jp

Sponsor
Institute	Univercity of Nagasaki
Institute
Department

Funding Source
Organization	Biogenomics 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	Univercity of Nagasaki
Address	1-1-1Manabino,Nagayo-cho,Nishisonogi-gun,Nagasaki,Japan,851-2195
Tel	0958135216
Email	katanaka@sun.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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 20 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	50
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 12 Month 14 Day
Date of IRB	2019 Year 11 Month 30 Day
Anticipated trial start date	2020 Year 01 Month 11 Day
Last follow-up date	2020 Year 03 Month 09 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 01 Month 15 Day
Last modified on	2020 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044230