NCT00938249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

Enrollment Period

7 months

First QC Date

July 10, 2009

Last Update Submit

April 23, 2010

Conditions

Hypertriglyceridemias

Keywords

Moderately Elevated Serum Triglyceride

Outcome Measures

Primary Outcomes (1)

  • Fasting triglyceride level

    Every 4 weeks (Overall 20 weeks)

Secondary Outcomes (4)

  • 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

    Every 4 weeks (Overall 20 weeks)

  • Serum adiponectin level

    Week 0 and Week 12

Study Arms (2)

Monascus Garlic Fermented Extract

EXPERIMENTAL
Dietary Supplement: Monascus Garlic Fermented Extract

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Monascus Garlic Fermented ExtractDIETARY_SUPPLEMENT
Monascus Garlic Fermented Extract
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Hiroshima, 734-8551, Japan

Location

Related Publications (1)

  • 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.

    PMID: 22041543DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 26, 2010

Record last verified: 2010-04

Locations

JP(1)