NCT00938249CompletedNot Applicable
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hiroshima University
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Fasting triglyceride level
Study Overview
Brief Summary
The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy as based on medical history and physical examination
- •Fasting serum triglyceride 120 to 200mg/dl
- •Willing not to serve as blood donor during the study
- •Informed consent signed
Exclusion Criteria
- •Female subjects who are pregnant or nursing a child
- •Participation in any clinical trial up to 90 days before Day 1 of this study
- •Renal or hepatic dysfunction
- •Heart disease
- •Under medication
- •Subjects who are taking functional food designed for weight loss or serum lipid reduction
Outcomes
Primary Outcomes
Fasting triglyceride level
Time Frame: Every 4 weeks (Overall 20 weeks)
Secondary Outcomes
- Abdominal circumference(Every 4 weeks (Overall 20 weeks))
- Visceral fat area by CT scan(Week 0 and Week 12)
- Serum total cholesterol and LDL cholesterol levels(Every 4 weeks (Overall 20 weeks))
- Serum adiponectin level(Week 0 and Week 12)
Investigators
Study Sites (2)
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