UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003154
Receipt number R000003827
Scientific Title Crossover trial of single ingestion of mulberry leaf extract on postprandial hyperglycemia in pre-diabetic subjects
Date of disclosure of the study information 2010/03/01
Last modified on 2010/02/09 15:26:04

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Basic information

Public title

Crossover trial of single ingestion of mulberry leaf extract on postprandial hyperglycemia in pre-diabetic subjects

Acronym

Crossover trial of single ingestion of mulberry leaf extract on postprandial hyperglycemia in pre-diabetic subjects

Scientific Title

Crossover trial of single ingestion of mulberry leaf extract on postprandial hyperglycemia in pre-diabetic subjects

Scientific Title:Acronym

Crossover trial of single ingestion of mulberry leaf extract on postprandial hyperglycemia 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 a mulberry leaf extract ingestion on blood glucose and insulin concentrations after a carbohydrate challenge

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Postprandial plasma glucose and serum insulin levels

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Carbohydrate-rich meal intake after ingestion of placebo; blood collection before and 30, 60, 90 and 120 min after the meal

Interventions/Control_2

Carbohydrate-rich meal intake after ingestion of mulberry leaf extract (low-dose); blood collection before and 30, 60, 90 and 120 min after the meal

Interventions/Control_3

Carbohydrate-rich meal intake after ingestion of mulberry leaf extract (middle-dose); blood collection before and 30, 60, 90 and 120 min after the meal

Interventions/Control_4

Carbohydrate-rich meal intake after ingestion of mulberry leaf extract (high-dose); blood collection before and 30, 60, 90 and 120 min after the meal

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

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyuki Kimura

Organization

National Agricultural Research Center for Tohoku Region

Division name

Biomass Research Team (Tohoku Region)

Zip code


Address

50 Harajukuminami, Arai, Fukushima

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Kimura

Organization

National Agricultural Research Center for Tohoku Region

Division name

Biomass Research Team (Tohoku Region)

Zip code


Address

50 Harajukuminami, Arai, Fukushima

TEL


Homepage URL


Email



Sponsor or person

Institute

National Agricultural Research Center for Tohoku Region

Institute

Department

Personal name



Funding Source

Organization

Ministry of Agriculture, Forestry and Fisheries of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tohoku University
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

2006 Year 10 Month 21 Day

Date of IRB


Anticipated trial start date

2006 Year 10 Month 01 Day

Last follow-up date

2006 Year 12 Month 01 Day

Date of closure to data entry

2007 Year 01 Month 01 Day

Date trial data considered complete

2007 Year 01 Month 01 Day

Date analysis concluded

2007 Year 01 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=R000003827


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name