Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level
Keywords
Abstract
Dates
| Last Verified: | 03/31/2010 |
| First Submitted: | 07/09/2009 |
| Estimated Enrollment Submitted: | 07/09/2009 |
| First Posted: | 07/12/2009 |
| Last Update Submitted: | 04/22/2010 |
| Last Update Posted: | 04/25/2010 |
| Actual Study Start Date: | 06/30/2009 |
| Estimated Primary Completion Date: | 01/31/2010 |
| Estimated Study Completion Date: | 01/31/2010 |
Condition or disease
Intervention/treatment
Dietary Supplement: Monascus Garlic Fermented Extract
Dietary Supplement: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Monascus Garlic Fermented Extract | Dietary Supplement: Monascus Garlic Fermented Extract |
| Placebo Comparator: Placebo | Dietary Supplement: Placebo |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Fasting triglyceride level [Every 4 weeks (Overall 20 weeks)]
Secondary Outcome Measures
1. Abdominal circumference [Every 4 weeks (Overall 20 weeks)]
2. Visceral fat area by CT scan [Week 0 and Week 12]
3. Serum total cholesterol and LDL cholesterol levels [Every 4 weeks (Overall 20 weeks)]
4. Serum adiponectin level [Week 0 and Week 12]
