Effect of Mulberry Leaf Extract on Blood Glucose
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 28, 2011
October 1, 2011
9 months
June 28, 2011
October 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Blood glucose change with meal tolerance test
0wk
Secondary Outcomes (10)
Blood glucose change with meal tolerance test
4wk
Insulin and C-peptide changes with meal tolerance test
0, 4 wk
Fasting blood glucose
0, 4 wk
Insulin
0, 4wk
C-peptide
0, 4wk
- +5 more secondary outcomes
Study Arms (2)
Mulberry leaf extract
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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
18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
Eligibility Criteria
You may qualify if:
- Age: over 20 years
- Fasting glucose: 100mg/dl ≤ \~ ≤ 125mg/dl
- HbA1c: \< 6.5%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ewha Womans Universitylead
- CHA Universitycollaborator
- Ministry of Knowledge Economy, Koreacollaborator
Study Sites (1)
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2011
First Posted
June 30, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 28, 2011
Record last verified: 2011-10