Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Hypertriglyceridemias
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Monascus Garlic Fermented Extract

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 734-8551
    • Hiroshima University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Experimental: Monascus Garlic Fermented Extract	Dietary supplement: Monascus Garlic Fermented Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting triglyceride level	Every 4 weeks (Overall 20 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hiroshima University
• Collaborators: Wakunaga Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Higashikawa F, Noda M, Awaya T, Ushijima M, Sugiyama M. Reduction of serum lipids by the intake of the extract of garlic fermented with Monascus pilosus: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2012 Apr;31(2):261-6. doi: 10.1016/j.clnu.2011.10.008. Epub 2011 Oct 29.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): April 26, 2010
• Last Update Submitted That Met QC Criteria: April 23, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Moderately Elevated Serum Triglyceride
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: eki-146