Effect of Mulberry Leaf Extract on Blood Glucose

Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose

The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.

Study Overview

• Status: Completed
• Conditions: Prediabetic State
• Intervention / Treatment: Dietary supplement: Mulberry leaf extract; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-Do
    • Seongnam, Gyeonggi-Do, Korea, Republic of
      • Bundang CHA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
Experimental: Mulberry leaf extract	Dietary supplement: Mulberry leaf extract; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood glucose change with meal tolerance test	0wk

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood glucose change with meal tolerance test	4wk
Insulin and C-peptide changes with meal tolerance test	0, 4 wk
Fasting blood glucose	0, 4 wk
Insulin	0, 4wk
C-peptide	0, 4wk
Glycated albumin	0, 4wk
High sensitivity C-reactive protein	0, 4wk
Oxidized low-density lipoprotein	0, 4wk
Malondialdehyde	0, 4wk
Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)	0, 4wk

Collaborators and Investigators

• Sponsor: Ewha Womans University
• Collaborators: CHA University; Ministry of Knowledge Economy, Korea
• Investigators: Principal Investigator: Sung Won Kwon, MD, CHA University; Principal Investigator: Seok Won Park, MD, CHA University; Principal Investigator: Moon Jong Kim, MD, CHA University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): October 28, 2011
• Last Update Submitted That Met QC Criteria: October 27, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: MLE_Biofood_2