UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046597 |
|---|---|
| Receipt number | R000053126 |
| Scientific Title | Study of effect of blood pressure suppression by intake of Mekabu |
| Date of disclosure of the study information | 2022/01/11 |
| Last modified on | 2022/06/06 14:23:43 |
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Basic information
Public title
Study of effect of blood pressure suppression by intake of Mekabu
Acronym
Study of effect of blood pressure suppression by intake of Mekabu
Scientific Title
Study of effect of blood pressure suppression by intake of Mekabu
Scientific Title:Acronym
Study of effect of blood pressure suppression by intake of Mekabu
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the blood pressure suppression effect on Japanese (20 to 64 years old) when ingest Mekabu for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure (systolic blood pressure, diastolic blood pressure) at the beginning of the test or after the intake for 4 weeks.
Key secondary outcomes
Salt intake, physical examination (body height, weight, BMI) and questionnaire on swelling (VAS) at the beginning of the test or after the intake for 4 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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
Intake of mekabu daily for 4 weeks.
Interventions/Control_2
none
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
| 65 | years-old | > |
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.Healthy Japanese who are 20 to 64 years old
3.Persons with systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 100 mmHg
4.Persons who satisfy 3 and the top of systolic blood pressure during the pre-intake test
Key exclusion criteria
1.Persons who have a chronic disease and is under medication, or has a serious disease history
2.Persons who are allergic to the test food
3.Persons who regularly take large amounts of the test food
4.Persons who regularly use medicines, specified insurance foods, health foods
5.Persons who have a history of hypertension treatment
6.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam
7.Persons who are judged inappropriate for the exam by the principal investigator
8.Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | mari |
| Middle name | |
| Last name | shimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
shimura.mari@hc-sys.jp
Public contact
Name of contact person
| 1st name | mari |
| Middle name | |
| Last name | shimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
shimura.mari@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Takaki Shoten Corporation
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
0368092722
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
| 2022 | Year | 01 | Month | 11 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 06 | 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
| 2022 | Year | 01 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053126
