UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024562
Receipt number 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 09:18:43

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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 or person

Institute

Niigata Bio-Research Park, Inc

Institute

Department

Personal name



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

Value
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