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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041524
Receipt No. 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 2020/09/28

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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
Email 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
Email pmaphs.OU@gmail.com

Sponsor
Institute Okayama University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2026 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
2020 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047403

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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