UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031450 |
|---|---|
| Receipt number | 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 09:08:36 |
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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
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
k.wasaki@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035903
