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

• Sponsor: Oregon State University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00764270
• Collaborator: Oregon Health and Science University (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 136
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Dietary Supplement: R-alpha lipoic acid	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and PlaceboCrossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lipoic acid treatment Participants take lipoic acid with a washout period before or after placebo.	Dietary Supplement: R-alpha lipoic acid; 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
Placebo Comparator: Placebo treatment Participants take placebo with a washout period before or after lipoic acid treatment	Dietary Supplement: R-alpha lipoic acid; 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

Outcome Measures

Primary Outcome Measures

1. hs-CRP [12,20 & 32 weeks]

   High sensitive C-reactive protein

Secondary Outcome Measures

1. 8-lso-PGF2a [12, 20 & 32 weeks]

   8-iso-prostaglandin F2alpha

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

• Principal Investigator: Gerd Bobe, PhD, Oregon State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerd Bobe, Principal Investigator, Linus Pauling Institute Associate Professor, Department of Animal and Rangeland Sciences, Oregon State University
• ClinicalTrials.gov Identifier: NCT00764270
• Other Study ID Numbers: AT002034-2 (7187); 5P01AT002034
• First Posted: Oct 2, 2008
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Gerd Bobe, Principal Investigator, Linus Pauling Institute Associate Professor, Department of Animal and Rangeland Sciences, Oregon State University: atherosclerosis; lipoic acid; thioctic acid; triglycerides; overweight; obesity; oxidative stress; inflammation
• Additional relevant MeSH terms: Atherosclerosis; Vascular Diseases; Thioctic Acid

Study Results

No Results Posted as of Apr 21, 2022