UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044468
Receipt number R000050568
Scientific Title The effects of Bifidobacterum on physical strength and body compositions in elderly residents: a randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2021/06/16
Last modified on 2022/06/09 10:03:06

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Basic information

Public title

Bifidobacterum and physical strength

Acronym

Bifidobacterum and physical strength

Scientific Title

The effects of Bifidobacterum on physical strength and body compositions in elderly residents: a randomized, double-blind, placebo-controlled trial

Scientific Title:Acronym

The effects of Bifidobacterum on physical strength and body compositions in elderly residents: a randomized, double-blind, placebo-controlled trial

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of Bifidobacterum on physical strength and body compositions in elderly residents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Grip strength

Key secondary outcomes

Body compositions


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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The participants consume 1 pack of powder containing 20 billion Bifidobacterum for 16 weeks.

Interventions/Control_2

The participants consume 1 pack of powder not containing Bifidobacterum for 16 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

85 years-old >

Gender

Male and Female

Key inclusion criteria

(1) 40 years old or over, and less than 85 years.
(2) Applicants who understand well the purpose and contents of this trial. Additionally, who can agree to participate by his/her will.

Key exclusion criteria

1) Persons with serious current or history of diseases (circulatory, metabolic, nervous, human immunodeficiency virus (HIV), malignant tumor, etc).
2) Allergy against milk or soybeans.
3) Intake of probiotics (foods, supplements, or drugs) twice or more times a week.
4) Participated in another clinical trial within 3 months.
5) Having disturbance in daily living activity (walking, carrying baggage, etc).
6) Judged to be ineligible by the principal investigator or doctor.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Tetsu
Middle name
Last name Kinoshita

Organization

Graduate School of Agriculture, Ehime University

Division name

Laboratory of Community Health and Nutrition

Zip code

790-8566

Address

3-5-7 Tarumi, Matsuyama, Ehime

TEL

089-946-9960

Email

tetsu.prospective@gmail.com


Public contact

Name of contact person

1st name Tetsu
Middle name
Last name Kinoshita

Organization

Institute of Community Life Sciences Co., Ltd.

Division name

Social Epidemiology Institute

Zip code

791-0243

Address

1383-2 Hiraimachi, Matsuyama-city, Ehime

TEL

089-904-7811

Homepage URL


Email

tetsu.prospective@gmail.com


Sponsor or person

Institute

Graduate School of Agriculture, Ehime 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

Ehime University Hospital Institutional Review Board

Address

Shitsukawa, Toon, Ehime

Tel

0899605172

Email

rinri@m.ehime-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 16 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

114

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

2021 Year 05 Month 24 Day

Date of IRB

2021 Year 05 Month 24 Day

Anticipated trial start date

2021 Year 10 Month 22 Day

Last follow-up date

2022 Year 05 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 08 Day

Last modified on

2022 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name