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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020536
Receipt No. 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

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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
Email 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
Email mikity@cam.med.osaka-u.ac.jp

Sponsor
Institute Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023144

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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