UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053620 |
|---|---|
| Receipt number | R000061189 |
| Scientific Title | Study on the effect of blood pressure suppression by single intake of test foods |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/04/17 09:54:40 |
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Basic information
Public title
Study on the effect of blood pressure suppression by single intake of test foods
Acronym
Study on the effect of blood pressure suppression by single intake of test foods
Scientific Title
Study on the effect of blood pressure suppression by single intake of test foods
Scientific Title:Acronym
Study on the effect of blood pressure suppression by single intake of test foods
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate blood pressure effect on Adults (18 to 64 years old) by single intake of test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure (systolic and diastolic blood pressure) change before and after intake.
Key secondary outcomes
Subjective evaluation of swelling
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Single intake of 4g of test food with 100mL of water
Interventions/Control_2
Single intake of 100mL of water
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 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. Adults 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 are allergic to the test food
3. Persons who usually take a large amount of test food
4. Persons who usually take medicine, specified health food, healthy food and supplements that may affect blood pressure
5. People who have a history of hospitalization for hypertension treatment
6. Persons with systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 100 mmHg
7. 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
8. Persons who were judged as inappropriate for study participants by the principal investigator
9. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
16
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
0368092722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Shimura |
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
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
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, 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
| 2024 | Year | 02 | Month | 15 | 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
4
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
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 06 | 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 | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061189
