Trial record 3 of 6 for:    Antioxidant | Open Studies | Exclude Unknown | NCCAM

Lipoic Acid and Prevention of Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Antioxidants
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Thioctic Acid
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 September 16, 2014