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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029345
Receipt No. R000033538
Scientific Title Exploratory test on the effect of test food on blood pressure
Date of disclosure of the study information 2017/10/01
Last modified on 2018/04/02

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Basic information
Public title Exploratory test on the effect of test food on blood pressure
Acronym Exploratory test on the effect of test food on blood pressure
Scientific Title Exploratory test on the effect of test food on blood pressure
Scientific Title:Acronym Exploratory test on the effect of test food on blood pressure
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate improvement effects of test food on high blood pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure after eight weeks ingestion of test food
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 eight weeks
Interventions/Control_2 Ingestion of placebo for eight 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
50 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy male and female 50 to 65 years at the time of informed consent
2)Visit systolic blood pressure is more than 130 mmHg and less than 159 mmHg or diastolic blood pressure is more than 85 mmHg and less than 99 mmHg in the screening test
3)Subjects who are estimated intaking daily salt is more than 8.0 g for men or more than 7.0 g for female in occasional urinalysis of screening tests
4)Subjects who are received sufficient explanation about purpose and content of this exam and have the capacity to consent and voluntarily write participation agreement in this examination voluntarily participate after understanding well
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 in the test period
5)Subjects who may change meal (the number of times meal, diet, alcohol intake)
6)Subjects who may change lifestyle (night work, long-term travel, relocation)
7)Subjects who smoke present or have smoked within the last one year prior to the current study
8)Subjects who was diagnosed as secondary hypertension
9)Women who are pregnant or may be pregnant
10)Women who are breast-feeding
11)Woman whose last menstruation has not passed more than one year
12)Subjects who donated 200 mL in the past month or more than 400 mL within 3 months (blood donation etc.)
13)Subjects who participated in other clinical trials within the past 3 months or currently participating in other clinical trials or planning to participate in other clinical trials during the examination period.
14)Subjects who may cause allergic to grape plant
15)Subjects who are judged as unsuitable for the study by the doctor
Target sample size 92

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Fukuda
Organization Fukuda Clinic
Division name Director
Zip code
Address Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka
TEL 06-6398-0203
Email fukuda@drmog.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
Address Senri Life Science Center 13F, 1-4-2 Shin-senrihigashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization FANCL Corporation
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
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
2017 Year 10 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
2017 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 14 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
2017 Year 09 Month 29 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033538

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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