The effect of black grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine

The effect of black grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine

A randomized controlled clinical trial with parallel groups, double-blind, on 50 patients. Stratified randomization based on migraine type and body mass index

Migraine patients will be selected from the patients referred to the neurology clinic of Khorshid Hospital in Isfahan City. Then the patients will be divided into two intervention (black grape seed extract) and control (placebo) groups. The duration of the intervention will be eight weeks. Anthropometric measures and biochemical factors will be assessed at the baseline and end of the intervention.

Inclusion criteria: willingness to participate in the study, diagnosed with migraine by a neurologist and according to the criteria of the International Classification of Headache Disorders-3 (ICHD-3), age 18 to 60 years, having at least one migraine attack per month, body mass index between 18.5 to 30. Non-inclusion criteria: suffering from tension-type headaches, chronic kidney diseases, cancer, and other neurological disorders, change in type and dosage of medications in the past month, taking supplements containing antioxidants and black grape seed extract in the past 3 months, following a special diet, pregnancy, and lactation.

Intervention group: Daily two capsules containing black grape seed extract for eight weeks. Control group: Two placebo capsules per day for eight weeks.

Migraine symptoms, migraine disability, calcitonin gene-related peptide, vascular cell adhesion molecule-1, total antioxidant capacity, and malondialdehyde

Correction of main outcome variables in the protocol abstract.

Randomization was done based on the stratified randomization method. To distribute patients into intervention and control groups, first, persons are classified into four states according to the type of migraine (with aura/without aura) and body mass index (18.5 to 24.9 and 25 to 30). Then, persons with the same conditions will be randomly assigned to two intervention and control groups. For this purpose, the first person who referred will be in the intervention group and the other person with the same conditions will be in the control group.

This study is a double-blind clinical trial study (participant, outcome assessor). The black grape seed extract supplement and its placebo (identical in terms of color, shape, and taste) will be packaged in similar boxes, and the participants and the outcome assessor will not be informed of the contents of the packages until the end of the study.