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Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

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ClinicalTrials.gov Identifier: NCT00938249
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : April 26, 2010
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by:
Hiroshima University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemias Dietary Supplement: Monascus Garlic Fermented Extract Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Monascus Garlic Fermented Extract Dietary Supplement: Monascus Garlic Fermented Extract
Placebo Comparator: Placebo Dietary Supplement: Placebo



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

Secondary Outcome Measures :
  1. Abdominal circumference [ Time Frame: Every 4 weeks (Overall 20 weeks) ]
  2. Visceral fat area by CT scan [ Time Frame: Week 0 and Week 12 ]
  3. Serum total cholesterol and LDL cholesterol levels [ Time Frame: Every 4 weeks (Overall 20 weeks) ]
  4. Serum adiponectin level [ Time Frame: Week 0 and Week 12 ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938249


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

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
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010

Keywords provided by Hiroshima University:
Moderately Elevated Serum Triglyceride

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