L-carnitine and Coenzyme Q10 in Relation to the Oxidative Stress, Antioxidant Enzymes Activities, Inflammation, and the Risk of Coronary Artery Disease

NCT ID: NCT01819701

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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Cardiovascular disease (CVD) is the leading cause of Taiwan. L-carnitine (LC) and coenzyme Q10 is recognized as lipid soluble antioxidants. The purposes of this study are going to investigate the relation of LC and coenzyme Q10 with the markers of lipid peroxidation, antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD) patients. The study is designed as a three-year study. The first year is an observation study. We will recruit CAD patients who are identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery, and age-gender matched healthy subjects. The concentrations of LC, coenzyme Q10, lipid peroxidation markers (TBARS and ox-LDL), antioxidant enzymes activities (catalase, glutathione peroxidase, glutathione reductase, and superoxide dismutase), and inflammatory markers are going to analysis. The second year is a single-blind, single dose intervention study. CAD subjects are recruit form the first year and randomly assigned to placebo, coenzyme Q10-150 (150 mg/d), coenzyme Q10-300 (300 mg/d), LC-1000 (1000 mg/d) or LC-2000 (2000 mg/d) groups. Intervention is going to administration for three months. Fasting blood will be obtained in each month and determine the concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes activities, and inflammatory markers after intervention. The third year is a single-blind, multiple doses intervention study. We are going to measure the CAD subjects from the second year intervention study. After three months washout period, the subjects are assigned to placebo, coenzyme Q10-150 plus LC-1000, coenzyme Q10-150 plus LC-2000, coenzyme Q10-300 plus LC-1000, and coenzyme Q10-300 plus LC-2000 groups. Intervention is going to administration for three months. Fasting blood will be obtained in each month and determine the concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes activities, and inflammatory markers after intervention. Hopefully, the results of this study could provide information of LC and coenzyme Q10 supplementation for clinical dietitian in advising CAD patients.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

starch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

LC and Coenzyme Q10

L-carnitine: 1000 mg/d and 2000 mg/d Coenzyme Q10: 150 mg/d and 300 mg/d

Group Type EXPERIMENTAL

LC-1000

Intervention Type DIETARY_SUPPLEMENT

L-carnitine 1000 mg /d

LC-2000

Intervention Type DIETARY_SUPPLEMENT

L-carnitine: 2000 mg/d

Q10-150

Intervention Type DIETARY_SUPPLEMENT

Coenzyme Q10: 150 mg/d

Q10-300

Intervention Type DIETARY_SUPPLEMENT

Coenzyme Q10: 300 mg/d

Interventions

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LC-1000

L-carnitine 1000 mg /d

Intervention Type DIETARY_SUPPLEMENT

LC-2000

L-carnitine: 2000 mg/d

Intervention Type DIETARY_SUPPLEMENT

Q10-150

Coenzyme Q10: 150 mg/d

Intervention Type DIETARY_SUPPLEMENT

Q10-300

Coenzyme Q10: 300 mg/d

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Verterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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Lee BJ, Lin JS, Lin YC, Lin PT. Effects of L-carnitine supplementation on lipid profiles in patients with coronary artery disease. Lipids Health Dis. 2016 Jun 17;15:107. doi: 10.1186/s12944-016-0277-5.

Reference Type DERIVED
PMID: 27317162 (View on PubMed)

Lee BJ, Lin JS, Lin YC, Lin PT. Effects of L-carnitine supplementation on oxidative stress and antioxidant enzymes activities in patients with coronary artery disease: a randomized, placebo-controlled trial. Nutr J. 2014 Aug 4;13:79. doi: 10.1186/1475-2891-13-79.

Reference Type DERIVED
PMID: 25092108 (View on PubMed)

Other Identifiers

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SF11263

Identifier Type: -

Identifier Source: org_study_id

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