UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024562
Receipt No. R000028261
Scientific Title Evaluation of suppressive effect of persimmon leaf powders on postpradial blood glucose levels.
Date of disclosure of the study information 2016/10/27
Last modified on 2017/04/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of suppressive effect of persimmon leaf powders on postpradial blood glucose levels.
Acronym Evaluation of suppressive effect of persimmon leaf powders on postpradial blood glucose levels.
Scientific Title Evaluation of suppressive effect of persimmon leaf powders on postpradial blood glucose levels.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenichi Watanabe
Organization Niigata Universty of Pharmacy and Applied Life Sciences
Division name Laboratory of Clinical pharmacology
Zip code
Address 265-1, Higashijima, Akiha-ku, Niigata City
TEL 0250-25-5267
Email watanabe@nupals.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Niigata Bio-Research Park, Inc
Organization Niigata Bio-Research Park, Inc
Division name Business promotion division
Zip code
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)

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 10 Month 27 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 10 Month 05 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.