UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014426
Receipt number 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 11:05:53

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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 or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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

Value
https://center6.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