Effect of Mulberry Leaf Extract on Blood Glucose

Not Applicable

Completed

• Conditions: Prediabetic State
• Interventions: Dietary Supplement: Mulberry leaf extract; Dietary Supplement: Placebo

• Registration Number: NCT01385865
• Lead Sponsor: Ewha Womans University

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mulberry leaf extract	Mulberry leaf extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Blood glucose change with meal tolerance test	0wk

Secondary Outcome Measures

Name	Time	Method
Malondialdehyde	0, 4wk
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
Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)	0, 4wk

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Seongnam, Gyeonggi-Do, Korea, Republic of