UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028861
Receipt number R000033029
Scientific Title A study to investigate the effects of food containing Bifidobacteria on body fat reduction: a randomized, double-blind, placebo controlled, parallel-group comparative study.
Date of disclosure of the study information 2018/04/01
Last modified on 2018/06/18 14:42:03

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Basic information

Public title

A study to investigate the effects of food containing Bifidobacteria on body fat reduction: a randomized, double-blind, placebo controlled, parallel-group comparative study.

Acronym

Effects of food containing Bifidobacteria on body fat reduction.

Scientific Title

A study to investigate the effects of food containing Bifidobacteria on body fat reduction: a randomized, double-blind, placebo controlled, parallel-group comparative study.

Scientific Title:Acronym

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

1st name
Middle name
Last name Yoshitaka Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code


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

1st name
Middle name
Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

President-director

Zip code


Address

Shibaura Omodaka Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



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)



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

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


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

2017 Year 07 Month 03 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name