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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014426
Receipt No. R000016789
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group clinical trial to study the effect of continuous ingestion of Bifidobacterium breve strain B-3 on body fat reduction.
Date of disclosure of the study information 2014/06/30
Last modified on 2015/04/21

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Basic information
Public title A randomized, double-blind, placebo-controlled, parallel-group clinical trial to study the effect of continuous ingestion of Bifidobacterium breve strain B-3 on body fat reduction.
Acronym A clinical trial to study the effect of continuous ingestion of Bifidobacterium B-3 on body fat reduction.
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group clinical trial to study the effect of continuous ingestion of Bifidobacterium breve strain B-3 on body fat reduction.
Scientific Title:Acronym A clinical trial to study the effect of continuous ingestion of Bifidobacterium B-3 on body fat reduction.
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of continuous ingestion of Bifidobacterium B-3 in the abatement of body fat, body weight and visceral fat by a placebo-controlled double-blind, randomized clinical trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Body composition (body weight, body fat percentage, BMI), abdominal visceral fat area
Key secondary outcomes Lipids metabolism parameters(T-Cho,HDL-Cho,LDL-Cho,TG,NEFA), blood glucose metabolism parameters (FBG, HbA1c, insulin), abdominal circumference, enteric environment (enterobacterial flora analysis, defecation frequency), inflammatory marker (hs-CRP), liver function (AST, ALT, gamma-GTP, ALP, LDH), total protein, albumin, cytokine (adiponectin, IL-6)

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 Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily ingestion of 2 capsules containing Bifidobacterium B-3 for 12 weeks.
Interventions/Control_2 Daily ingestion of 2 placebo capsules devoid of Bifidobacterium B-3 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects who have BMI ranging from 23 to 30
2.Subjects who give written informed consent prior to the study.
Key exclusion criteria 1.Subjects who have serious disease (cerebrovascular, heart, liver, kidney, gastrointestinal, endocrine metabolic diseases, infectious diseases that requires notification)
2.Subjects with a history of gastro
-intestinal related cancer or those who undertake medication or treatment for such disease
3.Subjects having a history of major surgery involving gastrectomy, gastrointestinal suture surgery, bowel resection, digestive system etc.
4.Subjects with irritable bowel
syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction
5.Subjects who is under medication or treatment for diabetes, dyslipidemia, high blood pressure
6.Subjects who regularly undertakes medication, treatment, functional food, nutraceuticals, or health supplements that affects bowel motion
7.Subjects who regularly take drugs, functional food, nutraceuticals or health supplements that affect serum lipids
8.Subjects who has defecation frequency less than thrice per week, or frequent symptoms of diarrhea
9.Subjects with frequent complaints of
post-menopausal symptoms
10.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data
11. Subjects with serious anemia
12. Subjects with a history of allergy to medicine and food
13. Heavy smoker and alcohol addict, or subjects with irregular lifestyle
14.Subjects who donated 400ml whole blood within past 12 weeks or 200ml whole blood within past 4 weeks or plasma or platelets within past 2 weeks prior to this study
15.Subjects who is pregnant or under lactation, or who is expected to be pregnant during the study
16.Subjects who is currently participating in or who had participated in other clinical trials within the last one month prior to this study
17.Subjects who are judged ineligible by our physician.


Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun Nishihira, M.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun Nishihira, M.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, Nishi Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Morinaga Milk Industry 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
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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 30 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
2014 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 25 Day
Last follow-up date
2014 Year 12 Month 07 Day
Date of closure to data entry
2015 Year 01 Month 08 Day
Date trial data considered complete
2015 Year 01 Month 15 Day
Date analysis concluded
2015 Year 03 Month 26 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 30 Day
Last modified on
2015 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016789

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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