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Effect of Mulberry Leaf Extract on Blood Glucose

This study has been completed.
Sponsor:
Collaborators:
Bundang CHA Medical Center
Ministry of Knowledge Economy, Korea
Information provided by (Responsible Party):
Oran Kwon, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01385865
First received: June 28, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes

June 28, 2011
October 27, 2011
January 2011
October 2011   (final data collection date for primary outcome measure)
Blood glucose change with meal tolerance test [ Time Frame: 0wk ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01385865 on ClinicalTrials.gov Archive Site
  • Blood glucose change with meal tolerance test [ Time Frame: 4wk ] [ Designated as safety issue: No ]
  • Insulin and C-peptide changes with meal tolerance test [ Time Frame: 0, 4 wk ] [ Designated as safety issue: No ]
  • Fasting blood glucose [ Time Frame: 0, 4 wk ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • C-peptide [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Glycated albumin [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • High sensitivity C-reactive protein [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Oxidized low-density lipoprotein [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Malondialdehyde [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Blood glucose change with meal tolerance test [ Time Frame: 4wk ] [ Designated as safety issue: No ]
  • Insulin and C-peptide changes with meal tolerance test [ Time Frame: 0, 4 wk ] [ Designated as safety issue: No ]
  • Fasting blood glucose [ Time Frame: 0, 4 wk ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • C-peptide [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Glycated albumin [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • hsCRP [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • ox-LDL [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • MDA [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Lipid profile(TG, total-cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol) [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Prediabetic State
  • 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
  • Dietary Supplement: Placebo
    18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
  • Experimental: Mulberry leaf extract
    Intervention: Dietary Supplement: Mulberry leaf extract
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01385865
MLE_Biofood_2
Yes
Oran Kwon, Ewha Womans University
Ewha Womans University
  • Bundang CHA Medical Center
  • Ministry of Knowledge Economy, Korea
Principal Investigator: Oran Kwon, Ph.D Ewha Womans University
Principal Investigator: Sung Won Kwon, MD Bundang CHA Medical Center
Principal Investigator: Seok Won Park, MD Bundang CHA Medical Center
Principal Investigator: Moon Jong Kim, MD Bundang CHA Medical Center
Ewha Womans University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP