UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037831 |
|---|---|
| Receipt number | R000043134 |
| Scientific Title | Effects of immune system on MRE ingreadients(fermentative degradation substances) liquid intake an open-label, randomized controlled trial |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/28 14:10:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043134
