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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025348
Receipt No. R000029176
Scientific Title The effect of a fermented green tea, Yamabuki Nadeshiko, on fasting blood glucose level
Date of disclosure of the study information 2016/12/21
Last modified on 2019/06/25

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Basic information
Public title The effect of a fermented green tea, Yamabuki Nadeshiko, on fasting blood glucose level
Acronym The effect of a fermented green tea on fasting blood glucose level
Scientific Title The effect of a fermented green tea, Yamabuki Nadeshiko, on fasting blood glucose level
Scientific Title:Acronym The effect of a fermented green tea on fasting blood glucose level
Region
Japan

Condition
Condition The healthy volunteers with pre-diabetes
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our purpose is to investigate whether Yamabuki Nadeshiko, a fermented green tea, improve fasting blood glucose level in healthy volunteers with pre-diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fasting blood glucose level
HbA1c (NGSP)
A glucose tolerance test
Key secondary outcomes 1.Insulin, HOMA-IR, Glico albumin
2.Blood Adiponectin level
3.Blood pressure
4.Blood and physical test
5.Cytokines and biological markers for diabetes and cardiovascular diseases

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Yamabuki Nadeshiko, a fermented green tea, 3g/day (1g/time) for 12 weeks
Interventions/Control_2 Placebo tea 3g/day (1g/time) for 12 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria Fasting blood glucose levels from 100 mg/dL to 126 mg/dL
Blood glucose levels from 140 mg/dL to 200 mg/gL after two-hour 75-gram oral glucose tolerance test
Key exclusion criteria 1) HbA1c (NGSP) under 6.5%
2) Treatment for heart failure, myocardial infarction, malignant neoplasm, and the other diseases
3) Chronic diseases such as atrial fibrillation, arrhythmia, hepatopathy, nephropathy, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and the others
4) Pregnancy, nursing, or a wish of pregnancy within next 6 months
5) The person who participates in other clinical trials at the time of this study entry
6) Smoker
7) Taking drugs, hyighly concentrated catechin-containing beverages, and a new supplement of effective for affecting blood glucose level
8) No agreement by documents
9) etc
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Morimoto
Organization University of Shizuoka
Division name Division of Molecular Medicine, School of Pharmaceutical Sciences
Zip code
Address 52-1, Yata, Suruga, Shizuoka, Shizuoka, Japan
TEL 054-264-5763
Email morimoto@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Morimoto
Organization University of Shizuoka
Division name Division of Molecular Medicine, School of Pharmaceutical Sciences
Zip code
Address 52-1, Yata, Suruga, Shizuoka, Shizuoka, Japan
TEL 054-264-5763
Homepage URL
Email yamabuki.shizuoka@gmail.com

Sponsor
Institute University of Shizuoka
Institute
Department

Funding Source
Organization OSADA Seicha Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Shizuoka General Hospital
SBS Shizuoka Health Promotion Center
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 静岡県立総合病院

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 21 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 12 Month 08 Day
Date of IRB
2016 Year 12 Month 08 Day
Anticipated trial start date
2016 Year 12 Month 08 Day
Last follow-up date
2018 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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