UMIN-CTR Clinical Trial

Basic information
Public title	Effects of immune system on MRE ingreadients(fermentative degradation substances) liquid intake an open-label, randomized controlled trial
Acronym	Effects of immune system on MRE ingreadients(fermentative degradation substances) liquid intake
Scientific Title	Effects of immune system on MRE ingreadients(fermentative degradation substances) liquid intake an open-label, randomized controlled trial
Scientific Title:Acronym	Effects of immune system on MRE ingreadients(fermentative degradation substances) liquid intake an open-label, randomized controlled trial
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of ingestion of test drinks on the improvement of intestinal environment and various immune functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma metabolome analysis Natural killer cell activity Defecation status
Key secondary outcomes	Visual Analogue Scale Chalder's fatigue scale Profile of Mood States 2nd Edition (Fecal metabolome analysis, Fecal IgA, *Consider whether the analysis will be performed after the test.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of test drink for 12 weeks
Interventions/Control_2	Not intake
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	40 years-old <=
Age-upper limit	64 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Subjects who are healthy men and women aged 40 to under 64 (2) Subjects who feel fatigue (3) Subjects who have trouble with defecation (4) Subjects who have received sufficient explanation about the purpose and content of the study, have the ability to consent, have voluntarily understood, volunteered to participate, and agreed to participate in the study in writing
Key exclusion criteria	(1) Subjects with a history of liver disease, kidney disease, gastrointestinal disease, heart disease, or other diseases that may affect the results of this study, or subjects with a history of surgery (2) Subjects with a disease currently being treated (3) Subjects with food and drug allergies (4) Subjects who have a habit of eating and drinking (5) Those who play intense sports and subjects who are on a diet (6) Subjects taking health foods and medicines that are expected to improve immunity and bowel movement (7) Subjects who may overdose food with a bowel movement improving effect during the study period (8) Subjects with anemia (9) Subjects whose life is irregular (10) Subjects who can not quit the intake of health food (including food for FOSHU and Foods with Function Claims') and designated quasi-drugs during the test period (11) Subjects who are taking medication (OTC drugs, including prescription drugs) continuously (12) Subjects who are excessively consuming alcohol or subjects who cannot ban alcohol from the day before the test to the day (13) Pregnant subjects or subjects who plan to become pregnant or breastfeed during the study period (14) Subjects who have participated in other clinical studies within 4 weeks from the start of this study, subjects who are currently participating in or plan to participate in the study (15) Subjects whose stool volume is equivalent to 1 or less quail eggs (16) Other subjects judged by the investigator as inappropriate
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	5300044
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	0661355200
Email	info@miura-cl.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Terashima
Organization	Oneness Support Co., Ltd.
Division name	Clinical Trial Division
Zip code	5300044
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	0648018917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	Souken. Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Miura Clinic, Medical Corporation Kanonkai IRB
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	0661355200
Email	mterashima@miura-cl.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	医療法人花音会みうらクリニック（大阪府）　Miura Clinic, Medical Corporation Kanonkai（Osaka）

Other administrative information
Date of disclosure of the study information	2019 Year 09 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	Preinitiation
Date of protocol fixation	2019 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date	2019 Year 09 Month 09 Day
Last follow-up date	2020 Year 01 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	2019 Year 08 Month 28 Day
Last modified on	2019 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043134