Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Dietary Supplement: Coenzyme Q10 Other: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
- Reducing lipid peroxidation and increasing antioxidant enzyme activities [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Pill |
Other: Placebo
Placebo controlled (dextrin)
|
| Experimental: Coenzyme Q10 |
Dietary Supplement: Coenzyme Q10
coenzyme Q10 supplements 60 mg/day and 150 mg/day
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Ping-Ting Lin, Ph.D. | +886-4-24730022 ext 11830 | apt810@csmu.edu.tw |
| Taiwan | |
| Taichung Verterans General Hospital | Recruiting |
| Taichung, Taiwan, 40705 | |
| Contact: Ping-Ting Lin, Ph.D. +886-4-24730022 ext 11830 apt810@csmu.edu.tw | |
More Information
No publications provided
| Responsible Party: | The Institutional Review Board of Taichung Veterans General Hospital, Taichung Veterans General Hospital |
| ClinicalTrials.gov Identifier: | NCT01163500 History of Changes |
| Other Study ID Numbers: | S07240 |
| Study First Received: | July 13, 2010 |
| Last Updated: | July 14, 2010 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Coenzyme Q10 Ubiquinone Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins |
ClinicalTrials.gov processed this record on May 23, 2013