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Lipoic Acid and Prevention of Heart Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765310
First Posted: October 2, 2008
Last Update Posted: September 22, 2017
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.
Collaborators:
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gerd Bobe, Oregon State University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Gerd Bobe, Oregon State University:

Primary Outcome Measures:
  • Triglycerides [ Time Frame: 12 weeks and 24 weeks ]

Secondary Outcome Measures:
  • Body weight and composition [ Time Frame: 12 and 24 weeks ]
  • Markers of inflammation and oxidative stress [ Time Frame: 12 and 24 weeks ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: November 2011 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
  More Information

Responsible Party: Gerd Bobe, Principal Investigator, Linus Pauling Institute; Associate Professor, Department of Animal Sciences, Oregon State University
ClinicalTrials.gov Identifier: NCT00765310     History of Changes
Other Study ID Numbers: AT002034-1 (7186)
5P01AT002034 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2008
First Posted: October 2, 2008
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by Gerd Bobe, 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
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances