Lipoic Acid and Prevention of Heart Disease
Phase 1
Completed
- Conditions
- Atherosclerosis
- Registration Number
- NCT00765310
- Lead Sponsor
- Oregon State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
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;
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Triglycerides 12 weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method Body weight and composition 12 and 24 weeks Markers of inflammation and oxidative stress 12 and 24 weeks
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Oregon Health & Science University🇺🇸Portland, Oregon, United States