Lipoic Acid and Prevention of Heart Disease

This study is currently recruiting participants.
Verified May 2013 by Oregon State University
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT00765310
First received: October 1, 2008
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Dietary Supplement: R-alpha lipoic acid
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease

Resource links provided by NLM:


Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • Triglycerides [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight and composition [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Markers of inflammation and oxidative stress [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  • Not on an extreme diet and maintaining a prudent diet;
  • Hs-CRP level at baseline of ≤ 10 mg/L;
  • Not smoking within the last three months;
  • Consuming ≤ 2 alcoholic drinks per day;
  • Not 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;
  • Not currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy;
  • Not 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;
  • Not having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study;
  • Not pregnant, breastfeeding, or planning to become pregnant before the end of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765310

Contacts
Contact: Jon Purnell, MD 503-494-1056 purnellj@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Jon Purnell, RN    503-494-1056    purnellj@ohsu.edu   
Principal Investigator: Jonathan Purnell, MD         
Sponsors and Collaborators
Oregon State University
Oregon Health and Science University
Investigators
Principal Investigator: Balz Frei, PhD Oregon State University
Principal Investigator: Jonathan Q Purnell, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT00765310     History of Changes
Other Study ID Numbers: AT002034-1, 5P01AT002034
Study First Received: October 1, 2008
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Oregon State University:
atherosclerosis
lipoic acid
thioctic acid
triglycerides
overweight
obesity
oxidative stress
inflammation

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 22, 2014