UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020536 |
|---|---|
| Receipt number | R000023144 |
| Scientific Title | The effect of the intake of Okinawa ingredients (Ipomoea aquatica) on postprandial glucose level |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2016/08/18 17:41:21 |
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Basic information
Public title
The effect of the intake of Okinawa ingredients (Ipomoea aquatica) on postprandial glucose level
Acronym
The effect of Okinawa ingredients (Ipomoea aquatica) on glucose level
Scientific Title
The effect of the intake of Okinawa ingredients (Ipomoea aquatica) on postprandial glucose level
Scientific Title:Acronym
The effect of Okinawa ingredients (Ipomoea aquatica) on glucose level
Region
| Japan |
Condition
Condition
Borderline diabetes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is Okinawa ingredients "Ipomoea aquatica" to examine the impact on glucose in borderline diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glucose level after the rice tolerance test (before eating riceafter 30 min, after 60 min, and comparing the value after 120 minutes)
Key secondary outcomes
glucose level after the rice tolerance test (Fluctuation rate, AUC (area under the curve))
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After eating rice 300g, before eating, after 30, 60 and 120 minutes measure the blood glucose level.
Interventions/Control_2
The Ensai 6g is taking those mixed with water 100 ~ 150ml, then eating rice 300g, before eating, after 30, 60 and 120 minutes measure the blood glucose level.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women from 20 years old to 85 years old
2. After receiving the explanation, those documents consent voluntary patient himself was obtained.
3. borderline diabetes (fasting blood glucose 110 ~ 125mg / dl)
Key exclusion criteria
1. Diabetic patient
2. Who is routinely regular use "Ensai"
3. Excessive smoking and alcohol addicts, diet is extremely and irregular person.
4. Persons with severe disease during treatment.
5. Diabetes, liver disease, kidney disease, underlying disease, such as heart disease is a serious condition, who require urgent treatment.
6. Person is a food allergy.
7. Breast-life, who during pregnancy, also a man of planning of pregnancy during the study period.
8. From the answer of the lifestyle questionnaire, the person who is determined to be unsuitable as a subject.
9. From the results of the blood test to be performed in the screening, people that have been determined to be unsuitable as a subject.
10. Human investigator has determined ineligible.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ohno |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2, Yamadaoka, Suita, OSAKA
TEL
06-6879-3498
ohno@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Sakaue |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2, Yamadaoka, Suita, OSAKA
TEL
06-6879-3498
Homepage URL
mikity@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Okinawa TLO Ltd.
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 02 | Month | 03 | 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
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 03 | 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
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023144
| Research Plan | |
|---|---|
| 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 |
