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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033199
Receipt No. 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

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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
Email 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
Email wakimoto@ughp-cpc.jp

Sponsor
Institute FANCL Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037853

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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