UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of the intake of a kale-containing green juice on blood pressure in adult males and females with a higher blood pressure.
Title of the study (Brief title)	A study for evaluating the effect of the intake of a kale-containing green juice on blood pressure in adult males and females with a higher blood pressure.
Region	Japan

Condition
Condition	healthy adult with a higher blood pressure
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the blood pressure reduction effects of intake of kale-containing green juice for 12 consecutive weeks in adult males and females with a higher blood pressure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Systolic blood pressure, diastolic pressure
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 a kale - containing food for 12 weeks.
Interventions/Control_2	Ingestion of placebo without a kale 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 64 years of age (2) Subjects who have a higher blood pressure in preliminary examination
Key exclusion criteria	(1) Subjects who routinely use green juice more than once per week (2) Subjects taking medicine, health food (including food for specified health use) and supplements which may influence blood pressure. (3) Subjects who have an allergy to plants of Brassicaceae including kale and metal, and may induce an allergy by participating in this study. (4) Subjects who have a disease under treatment (except hay fever sufferer without treatment during this study period and subjects with asthenopia only using eye drops). (5) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) (6) Subjects taking warfarin potassium (vitamin k-dependent coagulation factor synthesis inhibitors). (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (9) Subjects who can not keep restriction and prohibited matter during this study period. (10) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas. (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (12)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	80

Research contact person
Name of lead principal investigator	Mihoko Kurokawa
Organization	Q'SAI CO., LTD.
Division name	Research and Development Department
Address	1-7-16Kusagae,Chuo-ku,Fukuoka-shi, Japan 810-8606
TEL	092-724-0855
Email	kurokawa@kyusai.co.jp

Public contact
Name of contact person	Kunihiko Wasaki
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.wasaki@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Q'SAI CO., LTD
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	2018 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 02 Month 27 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 02 Month 23 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035903