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

Phase 2

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: R-alpha lipoic acid

• Registration Number: NCT00764270
• Lead Sponsor: Oregon State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Study Start: 2011-08
• Primary Completion: 2011-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo treatment	R-alpha lipoic acid	Participants take placebo with a washout period before or after lipoic acid treatment
Lipoic acid treatment	R-alpha lipoic acid	Participants take lipoic acid with a washout period before or after placebo.

Primary Outcome Measures

Name	Time	Method
hs-CRP	12,20 & 32 weeks	High sensitive C-reactive protein

Secondary Outcome Measures

Name	Time	Method
8-lso-PGF2a	12, 20 & 32 weeks	8-iso-prostaglandin F2alpha

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States