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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01385865 |
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Date of registration:
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28/06/2011 |
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Primary sponsor: |
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Public title:
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Effect of Mulberry Leaf Extract on Blood Glucose
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Scientific title:
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Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01385865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Moon Jong Kim, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bundang CHA Medical Center |
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Name:
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Seok Won Park, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bundang CHA Medical Center |
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Name:
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Sung Won Kwon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bundang CHA Medical Center |
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Name:
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Oran Kwon, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ewha Womans University |
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Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prediabetic State
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Intervention(s)
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Dietary Supplement: Mulberry leaf extract
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Blood glucose change with meal tolerance test
[Time Frame: 0wk]
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Secondary Outcome(s)
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Blood glucose change with meal tolerance test
[Time Frame: 4wk]
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C-peptide
[Time Frame: 0, 4wk]
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Fasting blood glucose
[Time Frame: 0, 4 wk]
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Glycated albumin
[Time Frame: 0, 4wk]
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High sensitivity C-reactive protein
[Time Frame: 0, 4wk]
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Insulin
[Time Frame: 0, 4wk]
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Insulin and C-peptide changes with meal tolerance test
[Time Frame: 0, 4 wk]
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Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)
[Time Frame: 0, 4wk]
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Malondialdehyde
[Time Frame: 0, 4wk]
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Oxidized low-density lipoprotein
[Time Frame: 0, 4wk]
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Secondary ID(s)
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MLE_Biofood_2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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