Dose Ranging Study of the Effects of Alpha Lipoic Acid on Oxidative Stress

NCT00857376 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2012-10-01

No results posted yet for this study

Summary

Heart disease is the most common cause of death in the United States and it is commonly found in people with diabetes and high cholesterol. Inflammation is one mechanism by which diabetes and elevated cholesterol damage blood vessels. Inflammation can be increased by oxidative stress. This study will see if Alpha Lipoic acid, a potent antioxidant and over the counter product, reduces blood levels of markers of oxidative stress and inflammation when compared with placebo. Placebo is a substance that looks like the real product, but contains no active product.

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

Alpha lipoic acid at 3 doses compared to placebo

This is a randomized study comparing the antioxidant effects of 3 doses of alpha lipoic acid (total of 600 mg daily, 1200 mg daily and 1800 mg daily) compared to placebo. These doses will be taken as 2 pills 3 times a day for 8 to 10 weeks.

Sponsors & Collaborators

Principal Investigators

  • Pamela Ouyang, MBBS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-08-31
Completion
2012-09-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00857376 on ClinicalTrials.gov