UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038132
Receipt number R000043411
Scientific Title A study for evaluating the effects of intake of fermented plant extract on intestinal environment
Date of disclosure of the study information 2019/10/01
Last modified on 2020/09/09 09:36:01

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Basic information

Public title

A study for evaluating the effects of intake of fermented plant extract on intestinal environment

Acronym

A study for evaluating the effects of intake of fermented plant extract on intestinal environment

Scientific Title

A study for evaluating the effects of intake of fermented plant extract on intestinal environment

Scientific Title:Acronym

A study for evaluating the effects of intake of fermented plant extract on intestinal environment

Region

Japan


Condition

Condition

Healthy Japanese adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of the test food on improving intestinal environment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Bacterial flora analysis on Weeks 0, 4, 8, and 12 after initiation.

Key secondary outcomes

Body weight, amount of body fat, amount of skin moisture, amount of moisture loss via the skin, hemoglobin concentration, and subjective symptoms on Weeks 0, 4, 8, and 12 after initiation.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test materials: Fermented plant extract supplement
Dose: 3 packs per day(5g x 3)
Administration: Take 1 pack of the test food after breakfast, lunch, and dinner.

Interventions/Control_2

Duration: 12 weeks
Test materials: Placebo control (not containing fermented plant extract)
Dose: 3 packs per day (5g x 3)
Administration: Take 1 pack of the test food after breakfast, lunch, and dinner.

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


Not applicable

Gender

Female

Key inclusion criteria

1. The age at the time of obtaining a consent is 20 years or older.
2. Female
3. Those from whom a written consent can be obtained on a voluntary basis.

Key exclusion criteria

The person who is unsuitable for the entry judged by an officer.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Motoko
Middle name
Last name Takaoka

Organization

Kobe College

Division name

School of Human Sciences, Department of Biosphere Sciences

Zip code

6628505

Address

4-1 Okadayama, Nishinomiyashi, Hyogo 662-8505 Japan

TEL

0798-51-8668

Email

takaoka@mail.kobe-c.ac.jp


Public contact

Name of contact person

1st name Nobutada
Middle name
Last name Murakami

Organization

Functional Food Creation Research Institute Co., Ltd.

Division name

Research and Development Dept.

Zip code

7161241

Address

4422-1 Yoshikawa, Kagagun Kibichuocho, Okayama 716-1241 Japan

TEL

0866-56-8771

Homepage URL


Email

n-murakami@kinousei.co.jp


Sponsor or person

Institute

Kobe College

Institute

Department

Personal name



Funding Source

Organization

Functional Food Creation Research Institute Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe College

Address

4-1 Okadayama, Nishinomiyashi, Hyogo 662-8505 Japan

Tel

0798-51-8668

Email

takaoka@mail.kobe-c.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

2019 Year 10 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

20

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

2019 Year 09 Month 20 Day

Date of IRB

2019 Year 09 Month 04 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 27 Day

Last modified on

2020 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043411


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name