Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

Hypertriglyceridemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938249
• Other study ID #: eki-146
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: April 23, 2010
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2010
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Hypertriglyceridemias

Intervention

Dietary Supplement:
• Monascus Garlic Fermented Extract

• Placebo

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Wakunaga Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting triglyceride level		Every 4 weeks (Overall 20 weeks)	No
Secondary	Abdominal circumference		Every 4 weeks (Overall 20 weeks)	No
Secondary	Visceral fat area by CT scan		Week 0 and Week 12	No
Secondary	Serum total cholesterol and LDL cholesterol levels		Every 4 weeks (Overall 20 weeks)	No
Secondary	Serum adiponectin level		Week 0 and Week 12	No