Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

Hiroshima University55 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Hypertriglyceridemias

Interventions

Monascus Garlic Fermented ExtractDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hiroshima University

Hiroshima, Hiroshima, Japan

Outcomes

Primary Outcomes

Fasting triglyceride level

Time frame: Every 4 weeks (Overall 20 weeks)

Secondary Outcomes

Abdominal circumference

Time frame: Every 4 weeks (Overall 20 weeks)

Visceral fat area by CT scan

Time frame: Week 0 and Week 12

Serum total cholesterol and LDL cholesterol levels

Time frame: Every 4 weeks (Overall 20 weeks)

Serum adiponectin level

Time frame: Week 0 and Week 12

Data from ClinicalTrials.gov

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