UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory test on the effect of test food on blood pressure
Title of the study (Brief title)	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	Masahiro Fukuda
Organization	Fukuda Clinic
Division name	Director
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	Tomohiro Sugino
Organization	Soiken Inc.
Division name	Representative Director
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033538