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 such as body weight and high blood cholesterol levels in overweight or obese participants.
Detailed description
The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants. Recruitment will be in the Portland, Oregon area.
Interventions
DIETARY_SUPPLEMENTR-alpha lipoic acid
600 mg in morning on empty stomach (two 300 mg capsules)
DIETARY_SUPPLEMENTPlacebo
two capsules once daily in morning on empty stomach
Sponsors
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Oregon State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-60 * Overweight (BMI, 25.0-29.9 kg/m2) or obese (BMI, \>30 kg/m2); * Elevated plasma triglycerides (100-400 mg/dl); * Weight stable for the last three months and at lifetime maximum; * Exercise limited to 30 minutes 3 times a week or less; * Hs-CRP level at baseline of ≤ 10 mg/L; * Consuming ≤ 2 alcoholic drinks per day;
Exclusion criteria
* Pregnant, breastfeeding, or planning to become pregnant before the end of the study. * Having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study * Diagnosed as having diabetes (fasting glucose \<125 mg/dl for entry), cardiovascular disease, congestive heart failure, angina, thyroid disorders, cancer, inflammatory disorders or renal, hepatic, or hematological abnormalities; * Currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy; * On an extreme diet and not maintaining a prudent diet; * 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; * Smoking within the last three months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglycerides | 12 weeks and 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Body weight and composition | 12 and 24 weeks |
| Markers of inflammation and oxidative stress | 12 and 24 weeks |
Countries
United States
Outcome results
None listed