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Completed

NCT Number: NCT01163500

Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients

Coenzyme Q10 (Ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the mitochondrial membrane and considered as a preventive factor for coronary artery disease (CAD). However, the relationships between coenzyme Q10 and the prevention of the risk of CAD are still inconsistent. The purposes of this study are to investigate the relation of coenzyme Q10 concentration with the blood lipid levels, plasma homocysteine, the markers of lipid peroxidation (TBARS, ox-LDL),antioxidant enzymes activities (catalase, glutathione peroxidase, superoxide dismutase)and to examine the association with the risk of CAD.The CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery (n = 100). The second year is a double-blind, placebo-controlled intervention study. CAD subjects (n = 60) are randomly assign to one of the three groups (coenzyme Q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). Intervention is going to administration for three months. The third year is a case-control study. The control group (n = 100) is comprised of healthy individuals with normal blood biochemical values, and match by age and gender with the first year CAD subjects (case group). Fasting blood samples will be obtain to determine the concentration of coenzyme Q10, homocysteine, the markers of lipid peroxidation,antioxidant enzymes activities. The differences between case and control groups will be compared by using Student's t-test. Conditional logistical regression model will be performed to calculate the odds ratio for CAD based on coenzyme Q10 level. Hopefully, the results of this study could provide the information to what has been know in CAD subjects. We expect coenzyme Q10 could be a preventive supplement to reduce the risk of CAD.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Taichung Verterans General Hospital

Taichung, 40705, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery

Exclusion criteria

  • age < 18 years old
  • pregnancy women
  • taking lowering lipid drug (Statin)

Treatment and study plan

Coenzyme Q10

Dietary Supplement

coenzyme Q10 supplements 60 mg/day and 150 mg/day

Placebo

Other

Placebo controlled (dextrin)

Primary outcomes

  1. Reducing lipid peroxidation and increasing antioxidant enzyme activities

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2010
Registry last updated
Oct 14, 2013

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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