Lipoic Acid and Prevention of Heart Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by (Responsible Party):
Balz Frei, Oregon State University
ClinicalTrials.gov Identifier:
NCT00765310
First received: October 1, 2008
Last updated: June 4, 2015
Last verified: June 2015
  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: July 2015
Estimated Primary Completion Date: July 2015 (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

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.

  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;
  • 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;
  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

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
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: Balz Frei, Director and Endowed Chair, Linus Pauling Institute, 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: June 4, 2015
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:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Thioctic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on July 27, 2015