UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053393 |
|---|---|
| Receipt number | R000060927 |
| Scientific Title | Study on the antihypertensive effect of supplementation |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2024/01/19 09:27:11 |
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Basic information
Public title
Study on the antihypertensive effect of supplementation
Acronym
Study on the antihypertensive effect of supplementation
Scientific Title
Study on the antihypertensive effect of supplementation
Scientific Title:Acronym
Study on the antihypertensive effect of supplementation
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the antihypertensive effect of the supplement when taken by adult males aged 18 to 65 for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic and diastolic blood pressure at 4, 8, and 12 weeks after intake
Key secondary outcomes
Physical examination (weight/BMI), blood test (general biochemistry), general urinalysis
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 3 tablets of the supplement with water before dinner every day for 12 weeks.
Interventions/Control_2
Take 3 tablets of the placebo food with water before dinner every day for 12 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
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 persons who are 18 years old or more and under 65 years old
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who have been diagnosed with hypertension by a doctor
3.Persons who have allergies to the test food
4.Persons who usually take a large amount of test food
5.Persons who usually take medicine, specified health food, healthy food and supplements that may affect blood pressure and salt absorption/excretion
6.Persons who have a drinking habit (drinking more than 1 go of sake per drinking day on 3 or more days a week)
7.Systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more
8.BMI less than 18.5 or greater than 30
9.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
10.Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYMEDICAL 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
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, 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
| 2024 | Year | 01 | Month | 19 | 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
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2024 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060927
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
