Effect of Mulberry Leaf Extract on Blood Glucose

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prediabetic State

Intervention / Treatment
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* Dietary Supplement: Mulberry leaf extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mulberry leaf extract<br> | Dietary Supplement: Mulberry leaf extract<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |