UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-finding study of persimmon leaf extract to assess the suppressive effect on postprandial blood glucose levels in healthy subjects
Title of the study (Brief title)	Dose-finding study of persimmon leaf extract to assess the suppressive effect on postprandial blood glucose levels in healthy subjects
Region	Japan

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

Objectives
Narrative objectives1	The optimum dose of persimmon leaf hot-water extract for the suppressive effect on postprandial blood glucose levels was evaluated by analyzing the time-dependent changes in postprandial blood glucose levels, the incremental area under curves (IAUC), and glycemic indexes (GI) after intakes of the placebo, low-, and high-dose extracts with Koshihikari boiled rice in 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	Time-dependent changes in postprandial IAUC and GI

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food-1: Low-dose extract (350 mL) and Koshihikari boiled rice(147g)
Interventions/Control_2	Test food-2: Low-dose extract (350 mL) and Koshihikari boiled rice(147g)
Interventions/Control_3	Control food: water (350 mL) colored with caramel and Koshihikari boiled rice(147g)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Body mass index (BMI) = <30. 2.Volunteers with no glucose intolelance in the past yesr. 3.Fasting plasma glucose 70-110mg/dl 4.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent. 5.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,and gastro-intestinal dedeases,judged to be inappropriate for this study. 3.Volunteers having risk of diabetes mellitus (fasting plasma glucose > = 110mg/dl and HbA1c > = 5.9%). 4.Volunteers rejected participating in this study by chief investigater.
Target sample size	10

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	nbrp-food-navi@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, Inc
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Niigata Bio-Research Park, Inc
Organization
Division
Category of Funding Organization	Profit organization
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 03 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 04 Day
Anticipated trial start date	2016 Year 03 Month 15 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 03 Month 15 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024766