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Antioxidant Functions of Lipoic Acid

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065624
First Posted: July 31, 2003
Last Update Posted: October 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Antioxidant Functions of Lipoic Acid

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 16
Study Start Date: November 2003
Study Completion Date: July 2007
Detailed Description:
As per Brief Summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065624


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: James M May, MD Vanderbilt University Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00065624     History of Changes
Other Study ID Numbers: R21AT001062-01A2 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2003
First Posted: July 31, 2003
Last Update Posted: October 2, 2007
Last Verified: September 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances