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Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

This study has been completed.
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by:
Hiroshima University
ClinicalTrials.gov Identifier:
NCT00938249
First received: July 10, 2009
Last updated: April 23, 2010
Last verified: April 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Fasting triglyceride level [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Abdominal circumference [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Visceral fat area by CT scan [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
  • Serum total cholesterol and LDL cholesterol levels [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Serum adiponectin level [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938249

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

No publications provided by Hiroshima University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hiroshima University ( Fumiko Higashikawa )
ClinicalTrials.gov Identifier: NCT00938249     History of Changes
Other Study ID Numbers: eki-146
Study First Received: July 10, 2009
Last Updated: April 23, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Hiroshima University:
Moderately Elevated Serum Triglyceride

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013