UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003155 |
|---|---|
| Receipt number | R000003830 |
| Scientific Title | Long-term trial on the effect of mulberry leaf extract ingestion on postprandial glycemic control in pre-diabetic subjects |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2010/02/09 15:58:09 |
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Basic information
Public title
Long-term trial on the effect of mulberry leaf extract ingestion on postprandial glycemic control in pre-diabetic subjects
Acronym
Long-term trial on the effect of mulberry leaf extract ingestion on postprandial glycemic control in pre-diabetic subjects
Scientific Title
Long-term trial on the effect of mulberry leaf extract ingestion on postprandial glycemic control in pre-diabetic subjects
Scientific Title:Acronym
Long-term trial on the effect of mulberry leaf extract ingestion on postprandial glycemic control in pre-diabetic subjects
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of long-term mulberry leaf extract ingestion on glycemic control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fasting blood glucose, insulin, 1,5-anhydroglucitol, glycated hemoglobin, glycated albumin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
placebo tablet ingestion three times daily before each meals for 12 weeks; blood collection at week 0, 4, 8 and 12 of the ingestion period and at 4-week after withdrawal
Interventions/Control_2
Mulberry leaf extract tablet ingestion three times daily before each meals for 12 weeks; blood collection at week 0, 4, 8 and 12 of the ingestion period and at 4-week after withdrawal
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fasting plasma glucose in the range of 100-140 mg/dl
Key exclusion criteria
pregnancy, lactation, severe medical illnesses, and the concurrent use of any agent for the control of blood glucose
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kariya |
Organization
Project M Co., Ltd.
Division name
President-director
Zip code
Address
T-Biz(306), 6-6-40 Aoba, Aramaki, Aoba-ku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Project M Co., Ltd.
Division name
President-director
Zip code
Address
T-Biz(306), 6-6-40 Aoba, Aramaki, Aoba-ku, Sendai
TEL
Homepage URL
Sponsor or person
Institute
Project M Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
National Agricultural Research Center for Tohoku Region
Nippon Medical School
Name of secondary funder(s)
Project M Co., Ltd.
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
総医研クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | 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
| 2008 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 09 | Day |
Last modified on
| 2010 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003830
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
