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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
  Purpose

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


Condition Intervention
Prediabetic State
 Dietary Supplement: Mulberry leaf extract
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Blood glucose change with meal tolerance test [ Time Frame: 0wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Dietary Supplement: Placebo
18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385865

Locations
Korea, Republic of
Bundang CHA Medical Center
Seongnam, Gyeonggi-Do, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Bundang CHA Medical Center
Ministry of Knowledge Economy, Korea
Investigators
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
  More Information

No publications provided

Responsible Party: Oran Kwon, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01385865     History of Changes
Other Study ID Numbers: MLE_Biofood_2
Study First Received: June 28, 2011
Last Updated: October 27, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013