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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036249
Receipt No. R000041287
Scientific Title Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Date of disclosure of the study information 2019/03/18
Last modified on 2019/03/18

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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