Lipoic Acid and Prevention of Heart Disease

Oregon State University (OSU)

Status and phase: Completed; Phase 1

Conditions: Atherosclerosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: R-alpha lipoic acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00765310

5P01AT002034 (U.S. NIH Grant/Contract)

AT002034-1 (7186)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Lipoic Acid

Active Comparator group

Description:

600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)

Treatment:

Dietary Supplement: R-alpha lipoic acid

Placebo

Placebo Comparator group

Description:

Placebo two caps every morning on empty stomach

Treatment:

Dietary Supplement: Placebo