UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021471 |
|---|---|
| Receipt number | R000024766 |
| Scientific Title | Dose-finding study of persimmon leaf extract to assess the suppressive effect on postprandial blood glucose levels in healthy subjects |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2016/06/15 16:02:05 |
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Basic information
Public title
Dose-finding study of persimmon leaf extract to assess the suppressive effect on postprandial blood glucose levels in healthy subjects
Acronym
Dose-finding study of persimmon leaf extract to assess the suppressive effect on postprandial blood glucose levels in healthy subjects
Scientific Title
Dose-finding study of persimmon leaf extract to assess the suppressive effect on postprandial blood glucose levels in healthy subjects
Scientific Title:Acronym
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
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
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
| 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
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
nbrp-food-navi@nbrp.co.jp
Sponsor or person
Institute
Niigata Bio-Research Park, Inc
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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 | 03 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024766
