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

This study is ongoing, but not recruiting participants.
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Balz Frei, Oregon State University Identifier:
First received: October 1, 2008
Last updated: June 4, 2015
Last verified: June 2015
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.

Condition Intervention Phase
Dietary Supplement: Crossover of R-alpha lipoic acid and placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of R-alpha Lipoic Acid in Treatment of Atherosclerotic Vascular Disease

Resource links provided by NLM:

Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • hs-CRP [ Time Frame: 12,20 & 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lipoic acid crossover with placebo
All participants take lipoic acid and placebo in a crossover design with a washout period.
Dietary Supplement: Crossover of R-alpha lipoic acid and placebo
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 placebo or 300 mg R-alpha-lipoic acid for 12 weeks


Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00764270

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon State University
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Balz Frei, PhD Oregon State University
  More Information

No publications provided

Responsible Party: Balz Frei, Director and Endowed Chair, Linus Pauling Institute, Oregon State University Identifier: NCT00764270     History of Changes
Other Study ID Numbers: AT002034-2  5P01AT002034 
Study First Received: October 1, 2008
Last Updated: June 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon State University:
lipoic acid
thioctic acid
oxidative stress

Additional relevant MeSH terms:
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Thioctic Acid
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins processed this record on February 04, 2016