Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

NCT ID: NCT00938249

Last Updated: 2010-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-02-28

Brief Summary

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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

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Conditions

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Hypertriglyceridemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Monascus Garlic Fermented Extract

Group Type EXPERIMENTAL

Monascus Garlic Fermented Extract

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Monascus Garlic Fermented Extract

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wakunaga Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Hiroshima University

OTHER

Sponsor Role lead

Locations

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Hiroshima University

Hiroshima, Hiroshima, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22041543 (View on PubMed)

Other Identifiers

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eki-146

Identifier Type: -

Identifier Source: org_study_id

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