UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief 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
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	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3659
Email	tsubokawa_masaya@fancl.co.jp

Public contact
Name of contact person	Takehara Isao
Organization	Clinical Support Corpration
Division name	Food Service Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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