Status:
COMPLETED
Lipoic Acid and Prevention of Heart Disease
Lead Sponsor:
Oregon State University
Collaborating Sponsors:
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Atherosclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 participan...
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 participan...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00765310
Start Date
April 1 2009
End Date
October 1 2024
Last Update
April 11 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97201