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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039629
Receipt No. R000044532
Scientific Title Influence on enteral environment of the plant fermented food and influence on physical condition
Date of disclosure of the study information 2020/03/01
Last modified on 2020/02/28

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Basic information
Public title Influence on enteral environment of the plant fermented food and influence on physical condition
Acronym Influence on enteral environment of the plant fermented food and influence on physical conditione
Scientific Title Influence on enteral environment of the plant fermented food and influence on physical condition
Scientific Title:Acronym Influence on enteral environment of the plant fermented food and influence on physical condition
Region
Japan

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

Objectives
Narrative objectives1 We will investgate the anmonia in the faces of the each subjects, before they take the femented food SOR39 and after 4 weeks afer subjects start the take it every day.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes we investigate the subjects faeces ammonia baseline and endline. Then, If the endline data decrease faeces ammonia level compare with baseline, the plant femmented food SOR39 is decerased the faeces ammonia level.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Prevention
Type of intervention
Food
Interventions/Control_1 4-week-intake of the plant femented food "SOR39" daily 2g
Interventions/Control_2 4-week-intake of placebo foods daily 2g
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,THere is no serious diseaes.
2,Not taking supplements to improve the bowel movement.
3,It is possible to maintain the day-to-day life.
4,The person whom a doctor allowed to take part in this study.
Key exclusion criteria 1,There is anything serious diseases.
2,The person with a food allergy.
3,pregnant women, breast-feeding women
4,The person whom a doctor don't allowed to take part in this study.
Target sample size 36

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 1708481
Address 3-34-3 Komagome Toshima-ku, Tokyo,JAPAN
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 clinic@eiyo.ac.jp

Sponsor
Institute Kawaga Nutrition University
Institute
Department

Funding Source
Organization Internanational Foods 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 Kagawa Nutrition University
Address 3-9-21 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 女子栄養大学 栄養クリニック

Other administrative information
Date of disclosure of the study information
2020 Year 03 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
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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 25 Day
Date of IRB
2019 Year 10 Month 23 Day
Anticipated trial start date
2019 Year 10 Month 25 Day
Last follow-up date
2021 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
2020 Year 02 Month 28 Day
Last modified on
2020 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044532

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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