UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study.
Title of the study (Brief title)	A study to assess the effect of Bifidobacteria ingestion on visceral fat reduction.
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effect of Bifidobacteria ingestion on reducing visceral fat in overweight adult.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	abdominal visceral fat area (Time frame: 12 weeks)
Key secondary outcomes	Body composition (body weight, body fat mass, body fat percentage, BMI, visceral fat area, subcutaneous fat area, total fat area), Waist circumference, Serum lipids (Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides), Diabetes associated markers (fasting plasma glucose, HbA1c, glycoalbumin, fasting serum insulin), liver function (AST, ALT, gamma-GTP, ALP), inflammatory marker (hs-CRP, LBP), enteric environment (enterobacterial flora analysis, defecation frequency)

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
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of probiotics (Bifidobacteria) for 12 weeks.
Interventions/Control_2	Ingestion of placebo 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who have BMI ranging from 25 to <30.
Key exclusion criteria	(1) Subjects who have history or receiving treatment of serious disease (2) Subject with gastrointestinal related disease and undertake medication (3) Subject who is under medication for diabetes, hypertension or dyslipidemia (4) Subject with a history of serious allergy to medicine and food (5) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study (6) Heavy smoker and heavy drinker, or subject with irregular lifestyle (7) Subject who is ineligible due to physician's judgment based on background of subject, physical finding, interview
Target sample size	80

Research contact person
Name of lead principal investigator	Satoshi Suzuki, M.D.
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical Examination and Treatment Management Family
Address	1-2-70 Konan, Minato-ku, Tokyo, 108-0075, Japan
TEL	03-3452-3381
Email	satoru_suzuki@sempos.or.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	President-director
Address	1-9-7 Shibaura, Minato-ku, Tokyo, 105-0023, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Hospital Organization Kyoto Medical Center
Name of secondary funｄer(s)

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	品川シーズンテラス健診クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 10 Day
Anticipated trial start date	2016 Year 09 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 02 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027542