UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Improvement effect of test food on high blood pressure
Title of the study (Brief title)	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	Hidenori Urata
Organization	Fukuoka University Chikushi Hospital
Division name	Department of cardiovascular Diseases,Professor
Address	818-8502 1-1-1 Zokumyoin, Chikushino ,Fukoka
TEL	092-921-1011
Email	uratah@fukuoka-u.ac.jp

Public contact
Name of contact person	Masaya Tsubokawa
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL	045-820-3659
Homepage URL
Email	tsubokawa_masaya@fancl.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital Department of cardiovascular Diseases
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027513