UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009408 |
|---|---|
| Receipt number | R000011055 |
| Scientific Title | Effectiveness research of Q'sai "Aojiru", against metabolic syndrome. |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2013/11/27 09:11:51 |
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Basic information
Public title
Effectiveness research of Q'sai "Aojiru", against metabolic syndrome.
Acronym
Intake effect of Q'sai "Aojiru"
Scientific Title
Effectiveness research of Q'sai "Aojiru", against metabolic syndrome.
Scientific Title:Acronym
Intake effect of Q'sai "Aojiru"
Region
| Japan |
Condition
Condition
Metabolic Syndrome
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of consumption of Q'sai Kale-based "Aojiru" against metabolic syndrome. To find effective intake and improved indicators from viewpoints of disease prevention and treatment assistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure
Neutral fat, LDL Cholesterol, HDL cholesterol,
Fasting Blood Sugar, HbA1c,
Body Mass Index, Waist,
Evaluated at the time of registration, intake start and end in 8 week.
Key secondary outcomes
Questionnaire on feeling effectiveness.
Evaluated at the time of registration, at the time of an intake start and end in 8 week.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of "Aojiru"
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Habitants who took a medical check in Arita
2) Person who are age from 30 to 74.
3) Person who correspond to the following at least one items.
1.Waist Male >= 85cm Female>=90cm
2.Fasting triglyceride >= 150mg/dL and/or HDL Cholesterol < 40mg/dL
3. SBP >= 120mmHg and/or DBP >= 80mmHg
4.Fasting Blood Sugar >= 110mg/dL
5. BMI >= 25kg/m2
6.LDL Cholesterol>=120mg/dL
4) Person who can consume the product continuously.
Key exclusion criteria
1) Person who takes regularly health care products including Q'sai "Aojiru" and other products .
2) Person whose latest clinical laboratory test results are significantly out of standard value and an investigator determined that he/she is required to take treatment.
3) Person who get an atrial fibrillation
4) Person who has critical disease history such as cardiac disease, cerebrovascular disease, kidney disease
5) Person who take warfarin potassium
6) Person who has allergies to plants of the Brassicaceae, including Kale.
7) Person who participated another clinical investigation or trial within 2 months from the start date of this study.
8) With other factors, an investigator determines that a person is unfit to participate the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomi Ide |
Organization
Kyushu University
Division name
Department of Cardiovascular medicine Kyushu University Graduate School of Medical Sciences
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5371
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisami Inuduka |
Organization
Hubit genomix, Inc.
Division name
Business Promotion Unit
Zip code
Address
79-5 Toshakuhei, Arita-cho Nishimatsuura-gun, Saga 844-0017, Japan
TEL
0955-43-3334
Homepage URL
hinuzuka@hubitgenomix.com
Sponsor or person
Institute
Q'SAI CO,Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
有田町 健康福祉課(佐賀県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 01 | 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
| 2012 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 14 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 27 | Day |
Last modified on
| 2013 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011055
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
