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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-01

Study Completion Date

2024-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lipoic acid treatment

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

Group Type ACTIVE_COMPARATOR

R-alpha lipoic acid

Intervention Type 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

Placebo treatment

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

Group Type PLACEBO_COMPARATOR

R-alpha lipoic acid

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No