The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

Study Overview
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Brief Summary
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The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.

Official Title
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The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

Conditions
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Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: R-alpha lipoic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction) Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months) Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P No tobacco use within 3 months of the study No laboratory evidence of renal, hepatic, or hematological abnormalities Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals; Elevated levels of urinary and plasma F2-isoprostanes Elevated plasma levels of hs-CRP

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipoic acid treatment<br>Participants take lipoic acid with a washout period before or after placebo. | Dietary Supplement: R-alpha lipoic acid<br>* 300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks<br>|
| Placebo Comparator: Placebo treatment<br>Participants take placebo with a washout period before or after lipoic acid treatment | Dietary Supplement: R-alpha lipoic acid<br>* 300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hs-CRP | High sensitive C-reactive protein | 12,20 & 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-lso-PGF2a | 8-iso-prostaglandin F2alpha | 12, 20 & 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation