Investigating the effect of training and spirulina supplement (Arthrospira platensis) on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life of women with migraine

Investigating the effect of spirulina supplementation on nitric oxide, lactate, inflammatory factor and oxidative status in women with migraine is investigated.

This study is a double blind randomized clinical trial. The block randomization method is used. The randomization unit is individual. The randomization tool is a random number table. The sample size is 90 people

We will select 90 women with migraine by sequential sampling method. After that, we will randomly divide the people into 2 groups receiving spirulina supplement and placebo. Then their fasting blood samples will be taken and to start the intervention. We will give 1000 mg of spirulina or placebo daily to each person in the intervention group. After 8 weeks, fasting blood samples will be taken to determine the relevant markers. And all laboratory personnel are kept blind to the assignment of study groups.

Inclusion criteria: Women with migraine Patients who agree to participate in the study. Diagnosis of migraine by a neurologist based on ICHD-3 criteria Age 18 to 60 years Non-entry criteria: History of any allergy, intolerance or adverse drug reaction to the study supplement Pregnancy and breastfeeding History of intestinal bypass Having cardiovascular diseases,diabetes, liver, kidney and thyroid diseases and malignancies and other neurological disorders Anticoagulants such as warfarin Patients with immune system disorders

The intervention for two months will be 1000 mg of spirulina supplement or placebo (starch) daily to each of the two groups.

The effect of spirulina supplementation on nitric oxide, lactate, inflammatory factor and oxidative status in women with migraine is investigated.

The random assignment of patients to two intervention and control groups is done by stratified permuted block randomization method. In this way, first, the eligible referring patients are classified according to age, body mass index, and contraceptive pills (OCP) consumption in the order of entry. BMI is considered normal (BMI = 18.5-24.9) and abnormal (BMI ≤ 25) and the age range of patients is 18 to 60 years. Therefore, patients are divided into two groups, 18-39 years old (younger) and 40-60 years old (older), based on the cut point in the middle of this range (39 years). The sample size in each group is 45 people (90 people in total). We use blocks of four with numbers 1 to 6 as follows (in each block, a means the intervention group and b means the control group): aabb-1 abba-2 abab-3 baba-4 baab-5 bbaa-6. By choosing the numbers using the random number table based on the numbers one to six, we select the above blocks in order and from left to right, we assign the qualified people of each stratum to one of the two groups a or b in the order of entry into the study . This selection is made 22 times and the first 88 qualified people are assigned to the groups. For the last two people, we use heads or tails to complete the sample list of 90 people and complete the balance.

Spirulina supplement and placebo will be available to the researcher in coded packages.The researcher gives each patient a package (containing supplements or placebo) and the delivery of the package is based on a code that has been specified for each participant (from the first to the ninety).Clinical caregivers, patients and researchers will not be aware of the content of the package, and only the collaborator of the project (who is responsible for the management of concealment and also has the randomization list) is aware of the list and the codes, who can reveal the code at the end of the study. In addition, the spirulina supplement and placebo will be completely identical in terms of appearance, color, smell and packaging.