Back to resultsThe Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Primary Purpose
Atherosclerosis
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R-alpha lipoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation
Eligibility Criteria
Inclusion Criteria:
- Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
- Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
- Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
- On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
- No tobacco use within 3 months of the study
- No laboratory evidence of renal, hepatic, or hematological abnormalities
- Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
- Elevated levels of urinary and plasma F2-isoprostanes
- Elevated plasma levels of hs-CRP
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lipoic acid treatment
Placebo treatment
Arm Description
Participants take lipoic acid with a washout period before or after placebo.
Participants take placebo with a washout period before or after lipoic acid treatment
Outcomes
Primary Outcome Measures
hs-CRP
High sensitive C-reactive protein
Secondary Outcome Measures
8-lso-PGF2a
8-iso-prostaglandin F2alpha
Full Information
NCT ID
NCT00764270
First Posted
October 1, 2008
Last Updated
April 19, 2022
Sponsor
Oregon State University
Collaborators
Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00764270
Brief Title
The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Official Title
The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
Collaborators
Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lipoic acid treatment
Arm Type
Active Comparator
Arm Description
Participants take lipoic acid with a washout period before or after placebo.
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Participants take placebo with a washout period before or after lipoic acid treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
R-alpha lipoic acid
Intervention Description
300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks
Primary Outcome Measure Information:
Title
hs-CRP
Description
High sensitive C-reactive protein
Time Frame
12,20 & 32 weeks
Secondary Outcome Measure Information:
Title
8-lso-PGF2a
Description
8-iso-prostaglandin F2alpha
Time Frame
12, 20 & 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
No tobacco use within 3 months of the study
No laboratory evidence of renal, hepatic, or hematological abnormalities
Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
Elevated levels of urinary and plasma F2-isoprostanes
Elevated plasma levels of hs-CRP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Bobe, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
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