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Completed

NCT Number: NCT00764270

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Body Weight Cardiovascular Diseases Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R-alpha lipoic acid

Dietary Supplement

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

Primary outcomes

  1. hs-CRP

    Time frame: 12,20 & 32 weeks

    High sensitive C-reactive protein

Secondary outcomes

  1. 8-lso-PGF2a

    Time frame: 12, 20 & 32 weeks

    8-iso-prostaglandin F2alpha

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Oregon Health and Science University

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2024
First posted
Oct 2, 2008
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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