Trial record 5 of 7 for:
Cardiovascular Disease | Open Studies | Exclude Unknown | NCCAM
Lipoic Acid and Prevention of Heart Disease
This study is currently recruiting participants.
Verified October 2012 by Oregon State University
Sponsor:
Oregon State University
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: October 18, 2012
Last verified: October 2012
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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 2013 |
| Estimated Primary Completion Date: | April 2013 (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: Sandy Bacon, RN | 503-494-2003 | bacons@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Sandy Bacon, RN 503-494-2003 bacons@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: | October 18, 2012 |
| 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:
|
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Atherosclerosis Arteriosclerosis 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 May 16, 2013