Aim: Endothelial dysfunction is a crucial contributor to the development of vascular problems. Nigella sativa L. seed oil which is commonly known as black seed oil is an antioxidant, anti-inflammatory and hypoglycemic agent that can be considered as an attractive candidate for improving endothelial dysfunction. Our objective is to evaluate the impact of Nigella sativa seed oil on intercellular adhesion molecule-1 (ICAM-1) and high sensitivity c-reactive protein (hsCRP), as well as quality of life of type 2 diabetic patients.
Methods: A prospective, randomized, placebo-controlled, double blinded study was conducted and registered in ClinicalTrials.gov (NCT03959306). Patients were randomly given either 1800 mg/day of black seed oil or placebo capsules for 12 weeks. Full clinical history, biochemical glycemic indices, lipid profile, kidney and liver functions, hsCRP, ICAM-1, as well as diabetes-39 questionnaire were assessed at baseline and end of the study.
Results: After 12 weeks, the levels of hemoglobin A1C, total cholesterol, triglycerides, hsCRP and ICAM-1, as well as diabetes control domain scores decreased significantly in intervention group compared to control group.
Conclusion: The administration of black seed oil over 12 weeks showed a superior efficacy over standard treatment alone in the management of type 2 diabetes mellitus and can be considered as therapeutic option for improving endothelial dysfunction.
Trial registration number: NCT03959306, Trial registration date: May, 2019.