Prediabetic State
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMulberry 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
DIETARY_SUPPLEMENTPlacebo
18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
Sponsors
CHA University
Ministry of Knowledge Economy, Korea
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose change with meal tolerance test | 0wk |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Blood glucose change with meal tolerance test | 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 |
| Glycated albumin | 0, 4wk |
Countries
South Korea
Outcome results
None listed