Lipoic Acid and Prevention of Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease

Conditions
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Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: R-alpha lipoic acid
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipoic Acid<br>600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules) | Dietary Supplement: R-alpha lipoic acid<br>* 600 mg in morning on empty stomach (two 300 mg capsules)<br>* Other names: Thioctic acid, LA, lipoic acid;|
| Placebo Comparator: Placebo<br>Placebo two caps every morning on empty stomach | Dietary Supplement: Placebo<br>* two capsules once daily in morning on empty stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides |  | 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight and composition |  | 12 and 24 weeks | 
| Markers of inflammation and oxidative stress |  | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, lipoic acid, atherosclerosis, thioctic acid, triglycerides, overweight, oxidative stress, inflammation