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Completed

NCT Number: NCT00938249

Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

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.

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Key information

Conditions

Hypertriglyceridemias Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monascus Garlic Fermented Extract

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Fasting triglyceride level

    Time frame: Every 4 weeks (Overall 20 weeks)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

Registry information

Official study title

Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Apr 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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