UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the intake of Okinawa ingredients (Ipomoea aquatica) on postprandial glucose level
Title of the study (Brief title)	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	Satoshi Ohno
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	2-2, Yamadaoka, Suita, OSAKA
TEL	06-6879-3498
Email	ohno@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Miki Sakaue
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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