Clinical trial NCT01385865: Effect of Mulberry Leaf Extract on Blood Glucose
Official title: Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
Collaborators: name: CHA University
name: Ministry of Knowledge Economy, Korea
First posted: 2011-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Blood glucose change with meal tolerance test
timeFrame: 0wk
Secondary outcomes:
measure: Blood glucose change with meal tolerance test
timeFrame: 4wk
measure: Insulin and C-peptide changes with meal tolerance test
timeFrame: 0, 4 wk
measure: Fasting blood glucose
timeFrame: 0, 4 wk
measure: Insulin
timeFrame: 0, 4wk
measure: C-peptide
timeFrame: 0, 4wk
measure: Glycated albumin
timeFrame: 0, 4wk
measure: High sensitivity C-reactive protein
timeFrame: 0, 4wk
measure: Oxidized low-density lipoprotein
timeFrame: 0, 4wk
measure: Malondialdehyde
timeFrame: 0, 4wk
measure: Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)
timeFrame: 0, 4wk
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-Do
Study officials:
affiliation: Ewha Womans University
name: Oran Kwon, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA University
name: Sung Won Kwon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA University
name: Seok Won Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA University
name: Moon Jong Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: