Effects of Monascus Garlic Fermented Extract on Serum Tri... | NCT00938249

Studies
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

NCT00938249

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Apr 26, 2010Estimated

Enrollment

55Actual

Phase

Not Applicable

Conditions

Hypertriglyceridemias

Interventions

Monascus Garlic Fermented Extract
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jul 10, 2009

First Submission Date that Met QC Criteria

Jul 10, 2009

First Posted Date

Jul 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2010

Last Update Posted Date

Apr 26, 2010Estimated

Name	Class
Wakunaga Pharmaceutical Co., Ltd.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monascus Garlic Fermented Extract	Experimental		Dietary Supplement: Monascus Garlic Fermented Extract
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monascus Garlic Fermented Extract	Dietary Supplement		Monascus Garlic Fermented Extract
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fasting triglyceride level		Every 4 weeks (Overall 20 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Abdominal circumference		Every 4 weeks (Overall 20 weeks)
Visceral fat area by CT scan		Week 0 and Week 12
Serum total cholesterol and LDL cholesterol levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima	Hiroshima	734-8551	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22041543	Derived	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases