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Effect of Mulberry Leaf Extract on Blood Glucose

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mulberry leaf extract
Placebo
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prediabetic State

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: over 20 years
  • Fasting glucose: 100mg/dl ≤ ~ ≤ 125mg/dl
  • HbA1c: < 6.5%

Exclusion Criteria:

  • Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit
  • Subject who has taken part in other clinical trials in 30 days prior to screening visit
  • Subject who is pregnant or breast feeding
  • Subject who lost body weight over 4 kg in 30 days prior to screening visit
  • Alcoholic
  • Heavy smoker (≥ 20 cigarettes/day)
  • Subject who has heart failure, coronary artery disease, uncontrolled hypertension (≥ 140/90mmHg), diabetes (fasting blood glucose ≥ 126mg/dL), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease
  • Subject who has an allergy to the ingredients of study product

Sites / Locations

  • Bundang CHA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mulberry leaf extract

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Blood glucose change with meal tolerance test

Secondary Outcome Measures

Blood glucose change with meal tolerance test
Insulin and C-peptide changes with meal tolerance test
Fasting blood glucose
Insulin
C-peptide
Glycated albumin
High sensitivity C-reactive protein
Oxidized low-density lipoprotein
Malondialdehyde
Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)

Full Information

First Posted
June 28, 2011
Last Updated
October 27, 2011
Sponsor
Ewha Womans University
Collaborators
CHA University, Ministry of Knowledge Economy, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01385865
Brief Title
Effect of Mulberry Leaf Extract on Blood Glucose
Official Title
Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
Collaborators
CHA University, Ministry of Knowledge Economy, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.
Detailed Description
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. After 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. They will intake placebo or mulberry leaf extract for 4 weeks. Biomarkers will be analyzed in blood samples in 0 and 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mulberry leaf extract
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Mulberry leaf extract
Intervention Description
18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
Primary Outcome Measure Information:
Title
Blood glucose change with meal tolerance test
Time Frame
0wk
Secondary Outcome Measure Information:
Title
Blood glucose change with meal tolerance test
Time Frame
4wk
Title
Insulin and C-peptide changes with meal tolerance test
Time Frame
0, 4 wk
Title
Fasting blood glucose
Time Frame
0, 4 wk
Title
Insulin
Time Frame
0, 4wk
Title
C-peptide
Time Frame
0, 4wk
Title
Glycated albumin
Time Frame
0, 4wk
Title
High sensitivity C-reactive protein
Time Frame
0, 4wk
Title
Oxidized low-density lipoprotein
Time Frame
0, 4wk
Title
Malondialdehyde
Time Frame
0, 4wk
Title
Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)
Time Frame
0, 4wk

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: over 20 years Fasting glucose: 100mg/dl ≤ ~ ≤ 125mg/dl HbA1c: < 6.5% Exclusion Criteria: Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit Subject who has taken part in other clinical trials in 30 days prior to screening visit Subject who is pregnant or breast feeding Subject who lost body weight over 4 kg in 30 days prior to screening visit Alcoholic Heavy smoker (≥ 20 cigarettes/day) Subject who has heart failure, coronary artery disease, uncontrolled hypertension (≥ 140/90mmHg), diabetes (fasting blood glucose ≥ 126mg/dL), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease Subject who has an allergy to the ingredients of study product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oran Kwon, Ph.D
Organizational Affiliation
Ewha Womans University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Won Kwon, MD
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seok Won Park, MD
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moon Jong Kim, MD
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang CHA Medical Center
City
Seongnam
State/Province
Gyeonggi-Do
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Mulberry Leaf Extract on Blood Glucose

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