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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031450
Receipt No. R000035903
Scientific 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.
Date of disclosure of the study information 2018/02/26
Last modified on 2019/02/25

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Basic information
Public 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.
Acronym 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.
Scientific 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Mihoko Kurokawa
Organization Q'SAI CO., LTD.
Division name Research and Development Department
Zip code
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
1st name
Middle name
Last name Kunihiko Wasaki
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
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)

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
2018 Year 02 Month 26 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
2018 Year 02 Month 19 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000035903

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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