UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041524 |
|---|---|
| Receipt number | R000047403 |
| Scientific Title | An uncontrolled open-label pre- and post-comparison study on usefulness of foods labeled with antihypertensive function and the characterization of the useful population for high normal and elevated blood pressure |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2023/01/01 12:04:30 |
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Basic information
Public title
Study on blood pressure lowering power of health food
Acronym
Change in blood pressure by health food
Scientific Title
An uncontrolled open-label pre- and post-comparison study on usefulness of foods labeled with antihypertensive function and the characterization of the useful population for high normal and elevated blood pressure
Scientific Title:Acronym
Usefulness of foods with antihypertensive function on prehypertension
Region
| Japan |
Condition
Condition
Prehypertension
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Study on the usefulness of foods with antihypertensive function for blood pressure in subjects with slight higher blood pressure
Basic objectives2
Others
Basic objectives -Others
Characteristic analysis of useful populations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the difference of the average SBP value after waking up during the last week (3-4 weeks) of the test food intake period with the average value during the previous observation period for each subject.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Foods containing piperine once a day for 4 weeks or
Food containing sardine peptide, once a day for 4 weeks or
Acetic acid-containing beverage, once a day for 4 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. SBP ranging from 120 to 160 mmHg in examination room during screening before obtaining consent
2. Mean home SBP after waking up will be from 115 to 145 mmHg in the pre-observation period
3. Those who are 20 years of age or older at the time of obtaining consent
4. Those who have given their free written consent after receiving sufficient explanation for participation in this research
Key exclusion criteria
1. Those who have been diagnosed as hypertension
2. Normal BP: examination room; less than120 (SBP) and 80 (DBP), home; less than115 (SBP) and 75 (DBP)
3. Those who have started one or more of diet, exercise, and/or drug therapy for hypertension
4. At the time of screening before obtaining consent, those who show hypertension criteria in the examination room blood pressure above Grade II hypertension
5. Those who have an average home blood pressure of 145-159 and/or 90-99 mmHg or higher after waking up during the previous observation period
6. Those who have any of histories of cerebral cardiovascular disease, nonvalvular atrial fibrillation, diabetes, or CKD with urinary protein, or who possessing three or more of the following: 65 years or older, male, dyslipidemia, smoking even if the mean home blood pressure after waking up will be elevated blood pressure (125-134 and/or 75-84 mmHg) or Grade I hypertension (135-144 and/or 85-89 mmHg) during the pre-observation period
7. Those with suspected secondary hypertension caused by CKD, endocrine disorders, sleep apnea syndrome, drug treatment
8. Patients with an uncontrolled diabetes
9. Patients with a history of myocardial infarction or unstable angina
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Noritaka |
| Middle name | |
| Last name | Ariyoshi |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6619
ariyoshi-n@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Noritaka |
| Middle name | |
| Last name | Ariyoshi |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6619
Homepage URL
pmaphs.OU@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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
| 2021 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047403
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
