The Combined Effects of Omega3 Fatty Acids and Nano- Curcumin Supplementation on Gene Expression and Serum Levels of Some Inflammatory and Endothelial Factors in Migraine Patients: Studyprotocol for a Randomized Controlled Trial

Migraine is a chronic nerves system disease leads to considerable disabilities and affected quality of life. Neuro-inflammation play a key role in progression of migraine which mainly caused by release of inflammatory mediators including COX-2 and iNOs enzymes, TNF-α،IL-1β،IL-6 and adhesion molecule such as ICAM and VCAM.Curcumin and omega 3 fatty acids with anti-inflammatory and neuro-protective effects can reduce gene expression and production of inflammatory mediators. The combination of omega-3 and curcumin have also synergistic effects which a lower dose can induce a positive effect. The aim of present study is to determine whether omega 3 fatty acids, curcumin or combined of them as a complement treatment in migraine is helpful and the reduction gene expression and serum levels of inflammatory markers.The study will be conducted involving 80 episodic migraine patients that withstratified randomization method based on sex, gender and body mass index (BMI) are classified into 4 groups: 1) receiving omega 3 fatty acid supplement (1.8 gr/ day) and nano-curcumin supplement (80 mg/ day) 2) receiving omega 3 fatty acid supplement and curcumin placebo 3) receiving curcumin supplement and omega 3 fatty acid placebo 4) receiving omega 3 fatty acid placebo and curcumin placebo for 2 mounts. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels oftarget inflammatory mediators including COX-2 and iNOs enzymes, TNF-α،IL-1β،IL-6 and adhesion molecule such as ICAM and VCAM will be measured before and after the trial. The data will be statistically evaluated using the most appropriate tests.The results of current study will determine the efficacy of therapeutic effects of curcumin, omega 3 fatty acids and combined of them as a new insight to control and treatment of migraine.