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

NCT00764270 | Completed Phase 2 DMC

• 2 other identifiers: AT002034-2 (7187)5P01AT002034
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

atherosclerosis; lipoic acid; thioctic acid; triglycerides; overweight; obesity; oxidative stress; inflammation

Outcome Measures

Primary Outcomes (1)

• hs-CRP

  High sensitive C-reactive protein

  12,20 & 32 weeks

Secondary Outcomes (1)

• 8-lso-PGF2a

  12, 20 & 32 weeks

Study Arms (2)

Lipoic acid treatment

ACTIVE COMPARATOR

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

Dietary Supplement: R-alpha lipoic acid

Placebo treatment

PLACEBO COMPARATOR

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

Dietary Supplement: R-alpha lipoic acid

Interventions

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

Lipoic acid treatment; Placebo treatment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Oregon State University: lead
• Oregon Health and Science University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Overweight; Obesity; Inflammation

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Gerd Bobe, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Linus Pauling Institute Associate Professor, Department of Animal and Rangeland Sciences

Model Details: Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: August 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: October 1, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-03

Locations

US (1)