search
Back to results

Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

Primary Purpose

Hypertriglyceridemias

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Monascus Garlic Fermented Extract
Placebo
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertriglyceridemias focused on measuring Moderately Elevated Serum Triglyceride

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hiroshima University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Monascus Garlic Fermented Extract

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Fasting triglyceride level

Secondary Outcome Measures

Abdominal circumference
Visceral fat area by CT scan
Serum total cholesterol and LDL cholesterol levels
Serum adiponectin level

Full Information

First Posted
July 10, 2009
Last Updated
April 23, 2010
Sponsor
Hiroshima University
Collaborators
Wakunaga Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00938249
Brief Title
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level
Official Title
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hiroshima University
Collaborators
Wakunaga Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemias
Keywords
Moderately Elevated Serum Triglyceride

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monascus Garlic Fermented Extract
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Monascus Garlic Fermented Extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fasting triglyceride level
Time Frame
Every 4 weeks (Overall 20 weeks)
Secondary Outcome Measure Information:
Title
Abdominal circumference
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Visceral fat area by CT scan
Time Frame
Week 0 and Week 12
Title
Serum total cholesterol and LDL cholesterol levels
Time Frame
Every 4 weeks (Overall 20 weeks)
Title
Serum adiponectin level
Time Frame
Week 0 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22041543
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

We'll reach out to this number within 24 hrs