Lipoic Acid and Prevention of Heart Disease

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00765310
• Other study ID #: AT002034-1 (7186)
• Secondary ID: 5P01AT002034
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2009
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• R-alpha lipoic acid
600 mg in morning on empty stomach (two 300 mg capsules)
• Placebo
two capsules once daily in morning on empty stomach

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon State University	National Center for Complementary and Integrative Health (NCCIH), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglycerides		12 weeks and 24 weeks
Secondary	Body weight and composition		12 and 24 weeks
Secondary	Markers of inflammation and oxidative stress		12 and 24 weeks