UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044117 |
|---|---|
| Receipt number | R000048570 |
| Scientific Title | Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2022/02/18 13:18:46 |
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Basic information
Public title
Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Acronym
Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Scientific Title
Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Scientific Title:Acronym
Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Basic objectives2
Others
Basic objectives -Others
Verification of effect on bowel movement by amazake long-term intake
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
alteration of intensional bacterial flora and effect on cold symptoms
Key secondary outcomes
Bowel movement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Amazake made by rice koji and sake lees is taken once a day
Interventions/Control_2
Placebo drink of control 3 is taken once a day
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Regular visitors to Matsuike Clinic (those with mild constipation who are prescribed magnesium oxide) or healthy adults recruited by expressing their intention to participate directly with the investigator.
2) Those who are 20 to 60 years old at the time of obtaining consent to participate in the exam
3) Those who have received sufficient explanation about the purpose and contents of this test, have the ability to consent, voluntarily volunteer to participate after understanding it well, and can consent to participate in this test in writing.
4) Those who can come to the hospital on the designated date and receive interviews
5) Those who the investigator deems appropriate to participate in this study
Key exclusion criteria
1) Persons with symptoms other than mild constipation
2) Those who cannot be judged by the investigator as having no influence on the participation in the examination regarding the medical history
3) Persons who may cause allergic symptoms to the ingredients contained in the test food
4) Those who habitually consume amazake (regardless of manufacturer)
5) Those planning to become pregnant, lactating or possibly pregnant and pregnant during the study period
6) Persons with alcoholism or other mental disorders
7) Persons who may change their lifestyle during the examination period (night shift, long-term travel, etc.)
8) Those who plan to take new health foods and supplement foods during the test period
9) Those who have been treated with hospitalization within the past 6 months
10) Those who are currently participating in other human clinical trials, those who have not passed 3 months since participating in other human clinical trials
11) Others who are judged by the investigator to be inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
MORINAGA & CO., LTD.
Division name
R & D Center
Zip code
230-8504
Address
2-1-1 Shimosueyoshi Turumi-ku Yokohama, Kanagawa
TEL
045-571-6140
s-mori-ab@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
MORINAGA & CO., LTD.
Division name
R & D Center
Zip code
230-8504
Address
2-1-1 Shimosueyoshi Turumi-ku Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
s-mori-ab@morinaga.co.jp
Sponsor or person
Institute
MORINAGA & CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA & 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
NPO MINS
Address
401 5-20-9 mita minato-ku Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
松生クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | 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
82
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
Main results already published
Date of protocol fixation
| 2020 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048570
