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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
LC-1000
LC-2000
Q10-150
Q10-300
Placebo
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Taichung Verterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

LC and Coenzyme Q10

Arm Description

starch

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

Outcomes

Primary Outcome Measures

Antioxidant
Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).
Anti-inflammation
Measure inflammatory markers:hs-CRP, TNF-alpha, and IL-6.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2013
Last Updated
March 12, 2014
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01819701
Brief Title
L-carnitine and Coenzyme Q10 in Relation to the Oxidative Stress, Antioxidant Enzymes Activities, Inflammation, and the Risk of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
starch
Arm Title
LC and Coenzyme Q10
Arm Type
Experimental
Arm Description
L-carnitine: 1000 mg/d and 2000 mg/d Coenzyme Q10: 150 mg/d and 300 mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
LC-1000
Intervention Description
L-carnitine 1000 mg /d
Intervention Type
Dietary Supplement
Intervention Name(s)
LC-2000
Intervention Description
L-carnitine: 2000 mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Q10-150
Intervention Description
Coenzyme Q10: 150 mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Q10-300
Intervention Description
Coenzyme Q10: 300 mg/d
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Antioxidant
Description
Antioxidant ability measurements: lipid peroxidation markers (MDA), antioxidant enzymes activities (catalase, glutathione peroxidase, and superoxide dismutase).
Time Frame
12 weeks
Title
Anti-inflammation
Description
Measure inflammatory markers:hs-CRP, TNF-alpha, and IL-6.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Taichung Verterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27317162
Citation
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.
Results Reference
derived
PubMed Identifier
25092108
Citation
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.
Results Reference
derived

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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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