Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

Hiroshima University

Status: Completed

Conditions: Hypertriglyceridemias

Treatments: Dietary Supplement: Monascus Garlic Fermented Extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00938249

eki-146

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

55 participants in 2 patient groups, including a placebo group

Monascus Garlic Fermented Extract

Experimental group

Treatment:

Dietary Supplement: Monascus Garlic Fermented Extract

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo