UMIN-CTR Clinical Trial

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
Institute	Kobe College
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043411