Back to resultsAntioxidant Functions of Lipoic Acid
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lipoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Lipoic acid, F2-isoprostanes, endothelial dysfunction, natural product
Eligibility 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.
Sites / Locations
- Vanderbilt University Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00065624
First Posted
July 29, 2003
Last Updated
September 28, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00065624
Brief Title
Antioxidant Functions of Lipoic Acid
Official Title
Antioxidant Functions of Lipoic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
As per Brief Summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Lipoic acid, F2-isoprostanes, endothelial dysfunction, natural product
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lipoic acid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M May, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antioxidant Functions of Lipoic Acid
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