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

NCT01163500 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2013-10-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Coenzyme Q10

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

OTHER

Placebo

Placebo controlled (dextrin)

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163500 on ClinicalTrials.gov