UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Title of the study (Brief title)	A clinical trial to study the effect of Bifidobacterium on VFA reduction.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the Bifidobacterium preparation on visceral fat area in the subjects with abdominal obesity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral Fat Area(VFA)
Key secondary outcomes	Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA),Body fat percentage

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food contained Bifidbacterium and N-acetylglucosamine, 4 capsules once day for 12weeks.
Interventions/Control_2	Control food not contained Bifidbacterium and N-acetylglucosamine, 4 capsules once a day for 12weeks.
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	1)BMI 25 - 30 kg/m2 2)Subjects who giving written informed consent
Key exclusion criteria	1)Subjects who take drug including Bifidbacterium or drug having an effect on intestinal functions. 2)Subjects who consecutively take dietary supplement or food including Bifidbacterium (more than three times a week for more than half year), and can't stop those foods during the test period. 3)Subjects who consecutively take dietary supplement or food including N-acetylglucosamine (more than three times a week for more than half year), and can't stop those foods during the test period. 4)Subjects who constantly use drugs and/or Kampo preparation and/or dietary supplement affecting the body fat. 5)Subjects who have colonic disease within 10 years (except polyp or infectious colitis). 6)Subjects who take medical treatment for obesity-related disease. (glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome, obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease) 7)Subjects who have severe disorders in liver function and/or kidney function. 8)Subjects who have medical history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, enterectomy, etc.). 9)Subjects who have allergy to medicine, shrimp, crab, milk or egg. 10)Subjects who can't discontinue dietary supplements for test period. 11)Subjects who are planned to participate in other clinical study. 12)Female with pregnancies, lactating or planning to become pregnant during the study. 13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	100

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute
Address	12-13 Kamishinano, Totuska-ku, Yokohama, kanagawa, Japan
TEL	045-820-3522
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	Isao Takehara
Organization	Clinical Support Corporation
Division name	PI Food Service Division
Address	4-1South 1 West 8, Chuo-ku, Sappori, 060-0061, Japan
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	Clinical Support Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	医療法人北武会　美しが丘病院（北海道） Medical Corporation Hokubukai Utsukushigaoka Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 10 Day
Anticipated trial start date	2016 Year 01 Month 12 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 01 Month 05 Day
Last modified on	2016 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023605