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Lipoic Acid and Prevention of Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00765310
Recruitment Status : Active, not recruiting
First Posted : October 2, 2008
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gerd Bobe, Oregon State University

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date May 11, 2018
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Triglycerides [ Time Frame: 12 weeks and 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00765310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • Body weight and composition [ Time Frame: 12 and 24 weeks ]
  • Markers of inflammation and oxidative stress [ Time Frame: 12 and 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipoic Acid and Prevention of Heart Disease
Official Title  ICMJE The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Dietary Supplement: R-alpha lipoic acid
    600 mg in morning on empty stomach (two 300 mg capsules)
    Other Name: Thioctic acid, LA, lipoic acid
  • Dietary Supplement: Placebo
    two capsules once daily in morning on empty stomach
Study Arms  ICMJE
  • Active Comparator: Lipoic Acid
    600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)
    Intervention: Dietary Supplement: R-alpha lipoic acid
  • Placebo Comparator: Placebo
    Placebo two caps every morning on empty stomach
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765310
Other Study ID Numbers  ICMJE AT002034-1 (7186)
5P01AT002034 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerd Bobe, Oregon State University
Study Sponsor  ICMJE Oregon State University
Collaborators  ICMJE
  • Oregon Health and Science University
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Gerd Bobe, PhD Oregon State University
Principal Investigator: Jonathan Q Purnell, MD Oregon Health and Science University
PRS Account Oregon State University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP