L-carnitine and Coenzyme Q10 in Relation to the Oxidative Stress, Antioxidant Enzymes Activities, Inflammation, and the Risk of Coronary Artery Disease
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ClinicalTrials.gov Identifier: NCT01819701 |
Recruitment Status :
Completed
First Posted : March 27, 2013
Last Update Posted : March 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Dietary Supplement: LC-1000 Dietary Supplement: LC-2000 Dietary Supplement: Q10-150 Dietary Supplement: Q10-300 Other: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
starch
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Other: Placebo |
Experimental: LC and Coenzyme Q10
L-carnitine: 1000 mg/d and 2000 mg/d Coenzyme Q10: 150 mg/d and 300 mg/d
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Dietary Supplement: LC-1000
L-carnitine 1000 mg /d Dietary Supplement: LC-2000 L-carnitine: 2000 mg/d Dietary Supplement: Q10-150 Coenzyme Q10: 150 mg/d Dietary Supplement: Q10-300 Coenzyme Q10: 300 mg/d |
- Antioxidant [ Time Frame: 12 weeks ]Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).
- Anti-inflammation [ Time Frame: 12 weeks ]Measure inflammatory markers:hs-CRP, TNF-alpha, and IL-6.
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Ages Eligible for Study: | 20 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clinical diagnosis of coronary artery disease (CAD): CAD patients were identified as having at least 50% stenosis of one major coronary artery by cardiac catheterization or as have received percutaneous transluminal coronary angioplasty (PTCA).
- Health subjects: Subjects did not have any illnesses and a history of gastrointestinal disorder, cardiovascular disease (showed normal electrocardiogram), hypertension, hyperlipidemia, liver and renal disease, diabetes, cancer, alcoholism or other metabolic disease and exhibited normal blood biochemical values, including fasting blood glucose < 6.11 mmol/L, blood urea nitrogen (BUN) < 7.9 mmol/L, creatinine < 123.8 umol/L, alkaline phosphates < 190 U/L, glutamic oxaloacetic transaminase (GOT) < 35 U/L and glutamic pyruvate transaminase (GPT) < 45 U/L.
- Must be able to swallow tablets
Exclusion Criteria:
- age < 20 years old
- pregnancy women
- taking antioxidant vitamins supplements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819701
Taiwan | |
Taichung Verterans General Hospital | |
Taichung, Taiwan, 40705 |
Responsible Party: | Taichung Veterans General Hospital |
ClinicalTrials.gov Identifier: | NCT01819701 |
Other Study ID Numbers: |
SF11263 |
First Posted: | March 27, 2013 Key Record Dates |
Last Update Posted: | March 13, 2014 |
Last Verified: | March 2014 |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Ubiquinone Coenzyme Q10 Micronutrients Physiological Effects of Drugs Vitamins |