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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003155
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Project M Co., Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003830

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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