Effect Of Oral Alpha Lipoic Acid On Preventing Cardiovascular Risk Factors Among Overweight Adults: A Double-blind, Randomized, Placebo-controlled, Cross-over Trial

Objectives: ALA is a naturally occurring disulfide compound and a cofactor of mitochondrial dehydrogenase complexes. Four antioxidant properties of ALA have been identified including its metal chelating capacity, its ability to scavenge ROS, its ability to regenerate endogenous antioxidants (vitamin E and C, etc) and its ability to repair oxidative damage. Recently, findings show that ALA is a much more promising antioxidant than others; however, to the best of our knowledge, no clinical trials are being conducted to examine whether ALA constitutes a promising and effective antioxidant therapy in obese humans. We aim to find a unique strategy to prevent CVD and T2D in obese humans. This RCT study will look at whether ALA supplement will decrease the levels of oxidative stress, CVD and T2D risk factors in obesity subjects. Methods: The 104 study samples were taken from kelamayi people's Hospital who meet inclusion criteria during the May to October 2009. Recruited subjects were randomly assigned to Group 1 or Group 2 in a 1:1 ratio balanced for gender. Group 1 will receive 8-week oral ALA intervention (1200mg/day) followed by placebo for 8-week, while Group 2 will receive 8-week placebo followed by ALA (1200mg/day) for 8-week. In both groups, a washout period of 28 days follows completion of the ALA/placebo study period. The participants and the research nurses who will interact with the participants for data collection were remained blinded to allocation throughout the study. We used RCT study to inspect whether ALA supplement will decrease the levels of oxidative stress, CVD and T2D risk factors in obesity subjects. Results: There are 104 study samples including 64 males and 40 females enrolled in the study, aged (41.8±7.1)years old. There was statistic difference (P<0.05) in body mass index, waist circumference, total cholesterol,HDLC and BaPWV between intervention and placebo group by General Lineal Model. Conclusion: This current DBRCT cross-over trial documents that an 8-week oral ALA supplement reduce the CVD and T2D risk by decreasing the levels of obesity, improving lipids profiles and arterial stiffness among overweight subjects.