UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000021511
Receipt number	R000024803
Scientific Title	Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults
Date of disclosure of the study information	2016/03/17
Last modified on	2017/01/25 17:34:54

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Basic information

Public title

Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults

Acronym

Safety evaluation of excessive intake of functional food containing lactic acid bacteria powder

Scientific Title

Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults

Scientific Title:Acronym

Safety evaluation of excessive intake of functional food containing lactic acid bacteria powder

Region

Japan

Condition

Healthy adults with or without a tendency for constipation

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

In order to investigate the safety of excessive consumption of food containing lactic acid bacteria powder for 4 weeks

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The incidence of side effects during intervention

Key secondary outcomes

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

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intervention
Test tablets (containing lactic acid bacteria powder)
Duration: 4 weeks
Amount: 4.4 g daily

Interventions/Control_2

Control
Placebo tablets
Duration: 4 weeks
Amount: 4.4 g daily

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Japanese untreated males and females from 20 to 69 years of age.
(2) Those judged as suitable for the study by the principal investigator.
(3) Those who gave the written informed consent before the study.

Key exclusion criteria

(1) A medical history of severe disorders, or continuous medical treatment.
(2) A surgical history of digestive system (except appendicectomy)
(3) Constantly usage of medical agents for constipation, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) for intestinal regulation.
(4) With allergy to lactic acid bacteria, milk, soybean, or citrus/
(5) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding.
(6) Those who drink alcohol a lot or heavy smoker.
(7) Those having an extremely irregular diet habit (unexpectedly skipping three or more meals a week)
(8) Alternative work schedule, or work on midnight shift.
(9) Those who are participating or plan to participate the other clinical tests (foods, medicines, cosmetics or liniments) during the study.
(10) Those judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Kazuhiko Takano

Organization

Medical Corporation Hokubukai

Division name

Utsukushigaoka Hospital

Zip code

Address

61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan

TEL

011-882-0111

Email

info@csc-smo.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

4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061, Japan

TEL

011-223-3130

Homepage URL

Email

takehara@csc-smo.co.jp

Sponsor or person

Institute

Clinical Support Corporation

Institute

Department

Personal name

Funding Source

Organization

Asahi Group Holdings, 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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 17 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

2016 Year 02 Month 25 Day

Date of IRB

Anticipated trial start date

2016 Year 03 Month 17 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 03 Month 17 Day

Last modified on

2017 Year 01 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024803

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name