UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of the plant fermentation food(super orient 39) intake for the putrefaction product in the feces.
Title of the study (Brief title)	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	Akira Tnaka
Organization	kagawa Nutrition University
Division name	Nutrition Clinic
Address	3-24-3,Komagome,Toshima,Tokyo.
TEL	03-3918-6181
Email	clinic@eiyo.ac.jp

Public contact
Name of contact person	Keiko Kmachi
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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