UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033199 |
|---|---|
| Receipt number | R000037853 |
| Scientific Title | Confirmation of hypotensive action by continued intake of combined supplements for adult males and females with normal high blood pressure or I degree high blood pressure -A randomized, double blind, placebo controlled, parallel study- |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/01/04 09:06:51 |
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Basic information
Public title
Confirmation of hypotensive action by continued intake of combined supplements for adult males and females with normal high blood pressure or I degree high blood pressure
-A randomized, double blind, placebo controlled, parallel study-
Acronym
Confirmation of hypotensive action by continued intake of combined supplements for adult males and females with normal high blood pressure or I degree high blood pressure
Scientific Title
Confirmation of hypotensive action by continued intake of combined supplements for adult males and females with normal high blood pressure or I degree high blood pressure
-A randomized, double blind, placebo controlled, parallel study-
Scientific Title:Acronym
Confirmation of hypotensive action by continued intake of combined supplements for adult males and females with normal high blood pressure or I degree high blood pressure
Region
| Japan |
Condition
Condition
Normal high blood pressure or I degree high blood pressure
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of hypotensive action by continued intake of combined supplements
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure after 12 -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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food consecutively for 12 weeks
Interventions/Control_2
Ingestion of placebo 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Males and females 20 to 64 years of age
(2)Subjects who are estimated daily salt intake is more than 8.0 g for men or more than 7.0 g for female in occasional urinalysis
(3)Subjects who are normal high blood pressure or I degree high blood pressure
Normal high blood pressure:More than 130 mmHg and less than 139 mmHg or diastolic blood pressure is more than 85 mmHg and less than 89 mmHg
I degree high blood pressure:More than 140 mmHg and less than 159 mmHg or diastolic blood pressure is more than 90 mmHg and less than 99 mmHg
(4)Subjects who can attend the examination site at the set visit date
(5) Subjects who agree to participate in the study and fill in the signature and date oneself before starting the study
Key exclusion criteria
(1)Subjects who are previous or present serious disease such digestive, liver, kidney, circulatory, blood, endocrine disorder
(2)Subjects who are taking medicine or being treated by a doctor
(3)Subjects who are intend to undergo treatment or medication by a doctor during the test period
(4)Subjects who plan to take specified healthy food, functionality food, supplement continuously in the test period
(5)Subjects who may change lifestyle(night work,long-term travel,relocation)
(6)Subjects who are overly smoking or intake alcohol
(7)Subjects who may cause allergic to grape plant
(8)Subjects who was diagnosed as secondary hypertension
(9)Women who are pregnant or may be pregnant
(10)Women who are breast-feeding
(11)Subjects who are planning to participate in other clinical trials during the examination period
(12)Subjects who are judged as unsuitable for the study by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3659
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehara Isao |
Organization
Clinical Support Corpration
Division name
Food Service Division
Zip code
Address
4-1 South 1 West 8, Chuo-ku, Sapporo 060-0061
TEL
080-5722-4308
Homepage URL
wakimoto@ughp-cpc.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 07 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | 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
| 2018 | Year | 06 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037853
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| Registered date | File name |
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