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

Oregon State University (OSU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Atherosclerosis

Treatments: Dietary Supplement: R-alpha lipoic acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00764270

5P01AT002034 (U.S. NIH Grant/Contract)

AT002034-2 (7187)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Lipoic acid treatment

Active Comparator group

Description:

Participants take lipoic acid with a washout period before or after placebo.

Treatment:

Dietary Supplement: R-alpha lipoic acid

Placebo treatment

Placebo Comparator group

Description:

Participants take placebo with a washout period before or after lipoic acid treatment

Treatment:

Dietary Supplement: R-alpha lipoic acid