Atherosclerosis
Conditions
Keywords
atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation
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.
Interventions
DIETARY_SUPPLEMENTR-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
Sponsors
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Oregon State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hs-CRP | 12,20 & 32 weeks | High sensitive C-reactive protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 8-lso-PGF2a | 12, 20 & 32 weeks | 8-iso-prostaglandin F2alpha |
Countries
United States
Outcome results
None listed