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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031846
Receipt No. R000034278
Scientific Title Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Date of disclosure of the study information 2018/03/23
Last modified on 2018/03/22

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Basic information
Public title Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Acronym Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Scientific Title Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Scientific Title:Acronym Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Region
Japan

Condition
Condition healthy poeple and mild constipation
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Super Orient 39 Plant fermented food intake 2 g per day for 2 weeks and measure the change of spoilage products indole, skatole, phenol, paracresol in feces.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of spoilage products indole, skatole, phenol, paracresol in feces
Key secondary outcomes Questionnaire survey on odor in feces was carried out.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The first period,The subjects intake super orient39 plant fermented food 2g per day for 2weeks. We checked their bloods and feces in baseline and 2weeks later.
After 4weeks wash out period,the second period started. The subject didn't intake the food for 2weeks. We checked thier bloods and feces baseline and 2weeks later.
Interventions/Control_2 The first period,The subject didn't intake the food for 2weeks. We checked thier bloods and feces baseline and 2weeks later.
After 4weeks wash out period,the second period started. The subjects intake super orient39 plant fermented food 2g per day for 2weeks. We checked their bloods and feces in baseline and 2weeks later.
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 didn't have serious disease.
2.The person was not taking supplments to improve the bowel movement.
3.It is possible to maintain the day-to-day life.
4.The person who is permitted by the doctor.
Key exclusion criteria 1.The person have serious disease.
2.The person have food allergy.
3.Pregnant and brest-feeding woman
4.The person who isn't permitted by the dicotor.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tnaka
Organization kagawa Nutrition University
Division name Nutrition Clinic
Zip code
Address 3-24-3,Komagome,Toshima,Tokyo.
TEL 03-3918-6181
Email clinic@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Kmachi
Organization Kagawa Nutrition University
Division name Nutrition Clinic
Zip code
Address 3-24-3 Komagome,Toshima,Tokyo
TEL 03-3918-6181
Homepage URL
Email Clinic@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

Funding Source
Organization International Food Co.,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
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
2018 Year 03 Month 23 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
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
2017 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 13 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
2018 Year 03 Month 22 Day
Last modified on
2018 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034278

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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