Lipoic Acid and Prevention of Heart Disease

Phase 2

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: R-alpha lipoic acid; Dietary Supplement: Placebo

• 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.

Study Timeline

• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Study Start: 2009-04
• Primary Completion: 2011-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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;

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipoic Acid	R-alpha lipoic acid	600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)
Placebo	Placebo	Placebo two caps every morning on empty stomach

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