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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046597
Receipt No. 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 2022/01/12

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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
Email 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
Email shimura.mari@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 12 Month 24 Day
Date of IRB
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 01 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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