UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023884 |
|---|---|
| Receipt number | R000027513 |
| Scientific Title | Improvement effect of test food on high blood pressure |
| Date of disclosure of the study information | 2016/09/02 |
| Last modified on | 2017/04/27 10:01:57 |
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Basic information
Public title
Improvement effect of test food on high blood pressure
Acronym
Improvement effect of test food on high blood pressure
Scientific Title
Improvement effect of test food on high blood pressure
Scientific Title:Acronym
Improvement effect of test food on high blood pressure
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate improvement effects on high blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure after twelve -weeks ingestion of test food
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food consecutively for twelve weeks
Interventions/Control_2
Ingestion of control food for twelve 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Visit systolic blood pressure is more than 130 mmHg and less than 160 mmHg in the screening test
2)20 to 80 years at the time of informed consent and possible to visit
3)BMI >=18.5 kg/m2 and <30kg/m2
4)Obtained informed consent in writing
Key exclusion criteria
1)Subjects who previous or present serious disease such digestive, liver, kidney, circulatory, blood, endocrine disorder
2)Subjects who are diagnosed with left ventricular hypertrophy
3)Subjects who are Secondary hypertension
4)Subjects who may cause allergic to grape plant
5)Subjects who are taking antihypertensive medicine or being treated by a doctor
6)Subjects who are intend to undergo treatment or medication by a doctor during the test period
7)Subjects who plan to take specified healthy food, functionality food, supplement in the test period
8)Subjects who may change meal (the number of times meal, diet, alcohol intake)
9)Subjects who may change lifestyle (night work, long-term travel, relocation)
10)Subjects who smoke present or have smoked within the last one year prior to the current study
11)Subjects who are estimated daily salt intake of less than 8.0 g of men or 7.0g of women at any time urinalysis in the screening test
12)Women who are pregnant or may be pregnant or are breast-feeding
13)Subjects who are planning to participate in other clinical study
14)Subjects who are judged as unsuitable for the study by the doctor for other reason
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Urata |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of cardiovascular Diseases,Professor
Zip code
Address
818-8502 1-1-1 Zokumyoin, Chikushino ,Fukoka
TEL
092-921-1011
uratah@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Tsubokawa |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL
045-820-3659
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital Department of cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Address
Tel
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
| 2016 | Year | 09 | Month | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027513
| 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 |
