Antioxidant Functions of Lipoic Acid

This study has been completed.

First Received: July 29, 2003 Last Updated: September 28, 2007 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00065624

Purpose

The goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: lipoic acid	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Antioxidant Functions of Lipoic Acid

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Antioxidants Cholesterol

Drug Information available for: Thioctic Acid

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	16
Study Start Date:	November 2003
Study Completion Date:	July 2007

Detailed Description:

As per Brief Summary

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Lipid criteria for inclusion are a plasma LDL between 160 and 190 mg/dl (total cholesterol usually 240-285 mg/dl)
Less than 2 coronary risk factors, and already on a cholesterol-lowering diet.

Exclusion criteria:

Overt or clinical atherosclerosis
Diabetes
Currently taking cholesterol-lowering medication.
Subjects with other lipid disorders
Subjects taking supplemental lipoic acid, vitamin C, or vitamin E.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065624

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

James M May, MD

Vanderbilt University

More Information

No publications provided

Study ID Numbers:	R21 AT001062-01A2
Study First Received:	July 29, 2003
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00065624 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Lipoic acid
F2-isoprostanes
endothelial dysfunction
natural product

Additional relevant MeSH terms:

Hyperlipidemias
Metabolic Diseases
Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Protective Agents

Pharmacologic Actions
Vitamins
Micronutrients
Hypercholesterolemia
Dyslipidemias
Thioctic Acid
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 05, 2009