Mina Darand1, Zahra Darabi1, Zahra Yari1, Saeedeh Saadati1, Mehdi Hedayati2, Ahmad Khoncheh3, Behnam Hosseini-Ahangar3, Seyed Moayyed Alavian3, Azita Hekmatdoost4. 1. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2. Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran. 4. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Azita.Hekmatdoost@cw.bc.ca.
Abstract
OBJECTIVE: The aim of this study was to assess the effects of Nigella sativa consumption on inflammatory biomarkers in patients with Non-alcoholic fatty liver disease (NAFLD). METHODS: This is a randomized, double-blind, placebo-controlled clinical trial. Fifty NAFLD patients were assigned to receive either two gram/day Nigella sativa seed as Nigella sativa group (NSG), or two gram/day starch as placebo group (PG) for 12 weeks. RESULTS: At the end of the study, the serum levels of tumor necrosis factor-α (TNF-α) decreased significantly compared with the beginning of the study in both groups, while the levels of high sensitive C reactive protein (hs-CRP) and nuclear factor kappa-B (NF-κB) only decreased significantly in the NSG (P 0 < 0.05). Only reduction in the serum levels of TNF-α was significantly more in NSG compared to the PG (P = 0.001). After adjusting the effects of confounding factors, the results remained unchanged. According to Fibroscan exam, hepatic steatosis and its percentage decreased significantly only in the NSG (P 0 < 0.005); however, the changes were not significantly different between two groups. After adjusting for confounding factors, only steatosis percentage reduction was significantly more in the NSG compared to PG (P = 0.005). CONCLUSION: Our results have shown that two gram/day consumption of Nigella sativa can reduce inflammatory biomarkers in patients with NAFLD. Further studies with different doses are highly recommended to find the optimal dosage.
RCT Entities:
OBJECTIVE: The aim of this study was to assess the effects of Nigella sativa consumption on inflammatory biomarkers in patients with Non-alcoholic fatty liver disease (NAFLD). METHODS: This is a randomized, double-blind, placebo-controlled clinical trial. Fifty NAFLD patients were assigned to receive either two gram/day Nigella sativa seed as Nigella sativa group (NSG), or two gram/day starch as placebo group (PG) for 12 weeks. RESULTS: At the end of the study, the serum levels of tumor necrosis factor-α (TNF-α) decreased significantly compared with the beginning of the study in both groups, while the levels of high sensitive C reactive protein (hs-CRP) and nuclear factor kappa-B (NF-κB) only decreased significantly in the NSG (P 0 < 0.05). Only reduction in the serum levels of TNF-α was significantly more in NSG compared to the PG (P = 0.001). After adjusting the effects of confounding factors, the results remained unchanged. According to Fibroscan exam, hepatic steatosis and its percentage decreased significantly only in the NSG (P 0 < 0.005); however, the changes were not significantly different between two groups. After adjusting for confounding factors, only steatosis percentage reduction was significantly more in the NSG compared to PG (P = 0.005). CONCLUSION: Our results have shown that two gram/day consumption of Nigella sativa can reduce inflammatory biomarkers in patients with NAFLD. Further studies with different doses are highly recommended to find the optimal dosage.