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The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764270
First Posted: October 2, 2008
Last Update Posted: September 25, 2017
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.
Collaborators:
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gerd Bobe, Oregon State University
  Purpose
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.

Condition Intervention Phase
Atherosclerosis Dietary Supplement: R-alpha lipoic acid Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

Resource links provided by NLM:


Further study details as provided by Gerd Bobe, Oregon State University:

Primary Outcome Measures:
  • hs-CRP [ Time Frame: 12,20 & 32 weeks ]
    High sensitive C-reactive protein


Secondary Outcome Measures:
  • 8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ]
    8-iso-prostaglandin F2alpha


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2018
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lipoic acid treatment
Participants take lipoic acid with a washout period before or after placebo.
Dietary Supplement: R-alpha lipoic acid
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
Placebo Comparator: Placebo treatment
Participants take placebo with a washout period before or after lipoic acid treatment
Dietary Supplement: R-alpha lipoic acid
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT00764270


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Oregon State University
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Gerd Bobe, PhD Oregon State University
  More Information

Responsible Party: Gerd Bobe, Principal Investigator, Linus Pauling Institute Associate Professor, Department of Animal and Rangeland Sciences, Oregon State University
ClinicalTrials.gov Identifier: NCT00764270     History of Changes
Other Study ID Numbers: AT002034-2 (7187)
5P01AT002034 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2008
First Posted: October 2, 2008
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Gerd Bobe, Oregon State University:
atherosclerosis
lipoic acid
thioctic acid
triglycerides
overweight
obesity
oxidative stress
inflammation

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances


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