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OpenTrials
Completed

NCT Number: NCT00765310

Lipoic Acid and Prevention of Heart Disease

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oregon Health & Science University

Portland, Oregon, 97201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

R-alpha lipoic acid

Dietary Supplement

600 mg in morning on empty stomach (two 300 mg capsules)

Other names: Thioctic acid, LA, lipoic acid

Placebo

Dietary Supplement

two capsules once daily in morning on empty stomach

Primary outcomes

  1. Triglycerides

    Time frame: 12 weeks and 24 weeks

Secondary outcomes

  1. Body weight and composition

    Time frame: 12 and 24 weeks

  2. Markers of inflammation and oxidative stress

    Time frame: 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2024
First posted
Oct 2, 2008
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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