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Effect of Mulberry Leaf Extract on Blood Glucose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385865
First Posted: June 30, 2011
Last Update Posted: October 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
CHA University
Ministry of Knowledge Economy, Korea
Information provided by (Responsible Party):
Oran Kwon, Ewha Womans University
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Oran Kwon, Ewha Womans University:

Primary Outcome Measures:
  • Blood glucose change with meal tolerance test [ Time Frame: 0wk ]

Secondary Outcome Measures:
  • Blood glucose change with meal tolerance test [ Time Frame: 4wk ]
  • Insulin and C-peptide changes with meal tolerance test [ Time Frame: 0, 4 wk ]
  • Fasting blood glucose [ Time Frame: 0, 4 wk ]
  • Insulin [ Time Frame: 0, 4wk ]
  • C-peptide [ Time Frame: 0, 4wk ]
  • Glycated albumin [ Time Frame: 0, 4wk ]
  • High sensitivity C-reactive protein [ Time Frame: 0, 4wk ]
  • Oxidized low-density lipoprotein [ Time Frame: 0, 4wk ]
  • Malondialdehyde [ Time Frame: 0, 4wk ]
  • Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) [ Time Frame: 0, 4wk ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385865


Locations
Korea, Republic of
Bundang CHA Medical Center
Seongnam, Gyeonggi-Do, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
CHA University
Ministry of Knowledge Economy, Korea
Investigators
Principal Investigator: Oran Kwon, Ph.D Ewha Womans University
Principal Investigator: Sung Won Kwon, MD CHA University
Principal Investigator: Seok Won Park, MD CHA University
Principal Investigator: Moon Jong Kim, MD CHA University
  More Information

Responsible Party: Oran Kwon, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01385865     History of Changes
Other Study ID Numbers: MLE_Biofood_2
First Submitted: June 28, 2011
First Posted: June 30, 2011
Last Update Posted: October 28, 2011
Last Verified: October 2011

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