UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041044 |
|---|---|
| Receipt number | R000046873 |
| Scientific Title | Verification of the reducing effect on oxidative stress by daily intake of miso soup made with miso paste |
| Date of disclosure of the study information | 2020/07/09 |
| Last modified on | 2021/01/07 11:12:04 |
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Basic information
Public title
Verification of the reducing effect on oxidative stress by daily intake of miso soup made with miso paste
Acronym
Verification of the reducing effect on oxidative stress by daily intake of miso soup made with miso paste
Scientific Title
Verification of the reducing effect on oxidative stress by daily intake of miso soup made with miso paste
Scientific Title:Acronym
Verification of the reducing effect on oxidative stress by daily intake of miso soup made with miso paste
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Do an exploratory evaluation of the reducing effect on oxidative stress for adults (over 20 years old) by miso soup intake for four weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxidative stress level (urinary 8-OHdG, urinary creatinine) at the beginning of or after the intake for four weeks.
Key secondary outcomes
Questionnaire(about defecation, stress and skin), urinary sodium, urinary indoxyl sulfate and urinary protein at the beginning of or after the intake for four weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake a cup of miso soup made with 18g "HONBA AKADASHI 500g" twice a day daily for four weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese who are over 20 years old
3.Persons who take five cups or less of miso soup a week
4.Persons who can continuously take miso soup made with Aka dashi during study
5.Persons who have lifestyle that are considered to have high oxidative stress according to the pre-questionnaire
Key exclusion criteria
1.Persons who have chronic illness,
2.Persons who are allergic to soy
3.Persons who daily use medicines, foods for specified health uses, health foods and supplements that may have anti oxidative effect
4.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
5.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasutake |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales planning Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
yasutake@hc-sys.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Matsumoto |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales Planning Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
080-4374-2722
Homepage URL
matsumoto@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MARUSAN-AI 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 09 | 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
30
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046873
