Lipoic Acid and Prevention of Heart Disease

April 19, 2022 updated by: Gerd Bobe, Oregon State University

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipoic Acid
600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)
Dietary supplement: R-alpha lipoic acid
600 mg in morning on empty stomach (two 300 mg capsules)
Other Names:
  • Thioctic acid, LA, lipoic acid
Placebo Comparator: Placebo
Placebo two caps every morning on empty stomach
Dietary supplement: Placebo
two capsules once daily in morning on empty stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Triglycerides
Time Frame: 12 weeks and 24 weeks
12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight and composition
Time Frame: 12 and 24 weeks
12 and 24 weeks
Markers of inflammation and oxidative stress
Time Frame: 12 and 24 weeks
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon State University

Collaborators

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

Investigators

  • Principal Investigator: Gerd Bobe, PhD, Oregon State University
  • Principal Investigator: Jonathan Q Purnell, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT002034-1 (7186)
  • 5P01AT002034 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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