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

NCT01163500 | Completed Phase 2 DMC

• 1 other identifier: S07240
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Reducing lipid peroxidation and increasing antioxidant enzyme activities

  12 weeks

Study Arms (2)

Pill

PLACEBO COMPARATOR

Other: Placebo

Coenzyme Q10

EXPERIMENTAL

Dietary Supplement: Coenzyme Q10

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

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

Coenzyme Q10

Placebo OTHER

Placebo controlled (dextrin)

Pill

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Verterans General Hospital

Taichung, 40705, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

TW (1)