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Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

This study has been completed.
Wakunaga Pharmaceutical Co., Ltd.
Information provided by:
Hiroshima University Identifier:
First received: July 10, 2009
Last updated: April 23, 2010
Last verified: April 2010
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.

Condition Intervention
Hypertriglyceridemias Dietary Supplement: Monascus Garlic Fermented Extract Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Fasting triglyceride level [ Time Frame: Every 4 weeks (Overall 20 weeks) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monascus Garlic Fermented Extract Dietary Supplement: Monascus Garlic Fermented Extract
Placebo Comparator: Placebo Dietary Supplement: Placebo


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00938249

Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Wakunaga Pharmaceutical Co., Ltd.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hiroshima University ( Fumiko Higashikawa ) Identifier: NCT00938249     History of Changes
Other Study ID Numbers: eki-146
Study First Received: July 10, 2009
Last Updated: April 23, 2010

Keywords provided by Hiroshima University:
Moderately Elevated Serum Triglyceride

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on June 26, 2017