UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of suppressive effect of persimmon leaf powders on postpradial blood glucose levels.
Title of the study (Brief title)	Evaluation of suppressive effect of persimmon leaf powders on postpradial blood glucose levels.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the suppressive effect of coingestion of persimmon leaf powders with white rice on postpradial blood glucose levels in high glycemic responders to white rice of healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time-dependent changes in postprandial blood glucose levels.
Key secondary outcomes	The incremental area under the blood glucose response curve (IAUC) and Glycemic index (GI) value.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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	Test meal: coingestion of persimmon leaf powders (3 g) in water (200 mL) with Koshihikari white rice (147 g) > Washout period: one week > Control meal: coingestion of water (200 mL) with Koshihikari white rice (147 g)
Interventions/Control_2	Control meal: coingestion of water (200 mL) with Koshihikari white rice (147 g) > Washout period: one week > Test meal: coingestion of persimmon leaf powders (3 g) in water (200 mL) with Koshihikari white rice (147 g)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Volunteers of high IAUC responders to white rice (3500 min mg/dL <, for 120 min) in healthy subjects, by finger-prick blood measurement at 0 (preintake), 15, 30, 45, 60, 90 and 120 min postintake of white rice. 2.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent. 3.Volunteers having screening test results judged to be appropriate for this study by investigator.
Key exclusion criteria	1.Volunteers having severe history of the diseases (liver, kidney, hert, blood) judged to be inappropriate for this study. 2.Volunteers received gastrectomy, enterectomy, or gastro-intestinal diseases, judged to be inappropriate for this study. 3.Diabetes mellitus. 4.Subjects who use oral medication affecting blood glucose. 5.Volunteers with any other medical reasons judged to be inappropriate by chief investigater.
Target sample size	15

Research contact person
Name of lead principal investigator	Kenichi Watanabe
Organization	Niigata Universty of Pharmacy and Applied Life Sciences
Division name	Laboratory of Clinical pharmacology
Address	265-1, Higashijima, Akiha-ku, Niigata City
TEL	0250-25-5267
Email	watanabe@nupals.ac.jp

Public contact
Name of contact person	Niigata Bio-Research Park, Inc
Organization	Niigata Bio-Research Park, Inc
Division name	Business promotion division
Address	316-2 Higashijima, Akiha-ku, Niigata, 956-0811, Japan
TEL	0250-25-1196
Homepage URL
Email	goto@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization	Niigata City Agricultural Development Research Center
Organization
Division
Category of Funding Organization	Local Government
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 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 05 Day
Anticipated trial start date	2016 Year 10 Month 28 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 10 Month 25 Day
Last modified on	2017 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028261