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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020434
Receipt No. R000023605
Scientific Title Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Date of disclosure of the study information 2016/12/01
Last modified on 2016/10/17

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Basic information
Public title Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Acronym A clinical trial to study the effect of Bifidobacterium on VFA reduction.
Scientific Title Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Scientific Title:Acronym 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
1st name
Middle name
Last name Kei Yui
Organization FANCL Corporation
Division name Research Institute
Zip code
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
1st name
Middle name
Last name Isao Takehara
Organization Clinical Support Corporation
Division name PI Food Service Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2015 Year 12 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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