Overview

This trial is active, not recruiting.

Condition atherosclerosis
Treatments r-alpha lipoic acid, placebo
Phase phase 2/phase 3
Sponsor Oregon State University
Collaborator Oregon Health and Science University
Start date April 2009
End date November 2011
Trial size 100 participants
Trial identifier NCT00765310, 5P01AT002034, AT002034-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)
r-alpha lipoic acid Thioctic acid, LA, lipoic acid
600 mg in morning on empty stomach (two 300 mg capsules)
(Placebo Comparator)
Placebo two caps every morning on empty stomach
placebo
two capsules once daily in morning on empty stomach

Primary Outcomes

Measure
Triglycerides
time frame: 12 weeks and 24 weeks

Secondary Outcomes

Measure
Body weight and composition
time frame: 12 and 24 weeks
Markers of inflammation and oxidative stress
time frame: 12 and 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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;

Additional Information

Official title The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
Principal investigator Balz Frei, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Oregon State University.