Hypertriglyceridemias
Conditions
Keywords
Moderately Elevated Serum Triglyceride
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.
Interventions
DIETARY_SUPPLEMENTMonascus Garlic Fermented Extract
DIETARY_SUPPLEMENTPlacebo
Sponsors
Wakunaga Pharmaceutical Co., Ltd.
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting triglyceride level | Every 4 weeks (Overall 20 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Serum total cholesterol and LDL cholesterol levels | Every 4 weeks (Overall 20 weeks) |
| Serum adiponectin level | Week 0 and Week 12 |
| Abdominal circumference | Every 4 weeks (Overall 20 weeks) |
| Visceral fat area by CT scan | Week 0 and Week 12 |
Countries
Japan
Outcome results
None listed