UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to investigate the effects of food containing Bifidobacteria on body fat reduction: a randomized, double-blind, placebo controlled, parallel-group comparative study.
Title of the study (Brief title)	Effects of food containing Bifidobacteria on body fat reduction.
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of food containing Bifidobacteria on anti-obesity effect in overweight adult.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body fat composition
Key secondary outcomes	Body composition , Waist circumference, Serum lipids, Diabetes associated markers, liver function, inflammatory marker, gut microbiota 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 test foods 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) Subject who have history of serious disease (2) Subject who is under medication for diabetes, hypertension or dyslipidemia (3) Subject with serious allergy to specific medicine or food (4) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study (5) Heavy smoker and heavy drinker (6) Subject who is ineligible due to physician's judgment based on background of subject, physical finding, interview
Target sample size	140

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashikodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	President-director
Address	Shibaura Omodaka Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
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	日本橋循環器科クリニック（東京都） Nihonbashi Cardiology Clinic

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 03 Day
Anticipated trial start date	2017 Year 09 Month 04 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	2017 Year 08 Month 28 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033029