UMIN-CTR Clinical Trial

Basic information
Public title	Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Acronym	Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Scientific Title	Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Scientific Title:Acronym	Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Plant Fermented Extract Powder Z Ingest 3 times the daily intake to confirm the safety of the food.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confirm the following offers from the subject: gastrointestinal disorder, vomiting, stomach discomfort, and feeling of fullness. Confirm the influence on the liver and kidney by subject's blood test Subjects take the food for 28 days.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subject takes the food for 28 days. Ingest 1g a day, equivalent to three times the amount of active ingredient 300mg daily, for 28 days. Perform blood tests and questionnaires before and after the test.
Interventions/Control_2
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)The person who does not take medicine for treatment. 2)The tendency to slight constipation (in a week 2-4 times) 3)The person who does not take bowel movement improvement medicine for examination one month. 4)The person who can do it constantly in live during the test days. 5)The person who was admitted by the judgment of the examination responsibility doctor.
Key exclusion criteria	1)The one with a serious disease. 2)person with a history of digestive disease and digestive surgery 3)The person who can not make life constant during examination 4) The person with allergy for the test food. 5)The person who is pregnant and hopes for the pregnancy during the examination. 6)The person who was not admitted by the judgment of the examination responsibility doctor.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Akira Middle name Last name Tanaka
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
Zip code	170-8481
Address	3-24-3 Komagome,Toshima-ku, Tokyo. 170-8481
TEL	0339186181
Email	clinic@eiyo.ac.jp

Public contact
1st name of contact person	1st name Keiko Middle name Last name Kamachi
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
Zip code	1708481
Address	3-24-3 Komagome,Toshima-ku, Tokyo.
TEL	0339186181
Homepage URL
Email	kamachi@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutrition University
Institute
Department

Funding Source
Organization	International Food Co.Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagawa Nutrition University
Address	3-12-9 Chiyoda, Sakado-shi, Saitama
Tel	0492832131
Email	clinic@eiyo.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 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Partially published

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 01 Month 09 Day
Date of IRB	2019 Year 01 Month 16 Day
Anticipated trial start date	2019 Year 01 Month 16 Day
Last follow-up date	2019 Year 03 Month 02 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 03 Month 18 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041287