Text Size

Antioxidant Functions of Lipoic Acid

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065624
First received: July 29, 2003
Last updated: September 28, 2007
Last verified: September 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Antioxidant Functions of Lipoic Acid

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00065624     History of Changes
Other Study ID Numbers: R21 AT001062-01A2
Study First Received: July 29, 2003
Last Updated: September 28, 2007
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:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antioxidants
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013