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

March 12, 2014 updated by: Taichung Veterans General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Verterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
starch
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antioxidant
Time Frame: 12 weeks
Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).
12 weeks
Anti-inflammation
Time Frame: 12 weeks
Measure inflammatory markers:hs-CRP, TNF-alpha, and IL-6.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taichung Veterans General Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SF11263

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