Clinical trial NCT00765310: Lipoic Acid and Prevention of Heart Disease
Official title: The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Keywords: atherosclerosis
lipoic acid
thioctic acid
triglycerides
overweight
obesity
oxidative stress
inflammation
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-10-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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;

Primary outcomes:
measure: Triglycerides
timeFrame: 12 weeks and 24 weeks
Secondary outcomes:
measure: Body weight and composition
timeFrame: 12 and 24 weeks
measure: Markers of inflammation and oxidative stress
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Gerd Bobe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Jonathan Q Purnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bobe G, Michels AJ, Zhang WJ, Purnell JQ, Woffendin C, Pereira C, Vita JA, Thomas NO, Traber MG, Frei B, Hagen TM. A Randomized Controlled Trial of Long-Term (R)-alpha-Lipoic Acid Supplementation Promotes Weight Loss in Overweight or Obese Adults without Altering Baseline Elevated Plasma Triglyceride Concentrations. J Nutr. 2020 Sep 1;150(9):2336-2345. doi: 10.1093/jn/nxaa203.