Standardized Nigella sativa seed oil ameliorates hepatic steatosis, aminotransferase and lipid levels in non-alcoholic fatty liver disease: A randomized, double-blind and placebo-controlled clinical trial.

2019-04
Journal of ethnopharmacology 234
- Ahmad Khonche
- Hasan Fallah Huseini
- Mahdi Gholamian
- Reza Mohtashami
- Farzaneh Nabati
- Saeed Kianbakht

PubMed: 30639231
DOI: 10.1016/j.jep.2019.01.009

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 120 patients with non-alcoholic fatty liver disease (NAFLD)
Methods: Randomized, placebo-controlled trial, 2.5 mL fully standardized N. sativa seed oil every 12 h for 3 months vs placebo
Duration: 3 months
Funding: Unclear

Ethnopharmacological evidence

Nigella sativa (N. sativa) seeds are used in the Iranian traditional medicine for the treatment of liver diseases.

Aim of study

To study the efficacy and safety of N. sativa seed oil in the treatment of patients with non-alcoholic fatty liver disease (NAFLD).

Materials and methods

Sixty patients received 2.5 mL fully standardized N. sativa seed oil every 12 h and 60 other patients received placebo for 3 months. At the baseline and endpoint, hepatic steatosis ultrasound grade and blood levels of triglycerides, LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol), ALT (alanine aminotransferase), AST (aspartate aminotransferase), blood urea nitrogen, creatinine and complete blood cell count as well as body mass index were determined in the oil and placebo groups and compared.

Results

Grade of hepatic steatosis was significantly reduced in the oil group compared to the placebo group (P = 0.004). Mean ± standard deviation of changes of variables in the oil and placebo groups were respectively 32.6 ± 16.6 and 14.2 ± 19.7% for ALT (P < 0/001), 29.4 ± 16.3 and 12.3 ± 16.8% for AST (P < 0.001), 10 ± 13.9 and 0.22 ± 18.2% for triglycerides (P = 0.001), 14.1 ± 9.8 and 9.2 ± 11.1% for LDL-C (P = 0.01), 9.5 ± 7.7 and 4.8 ± 6.5% for HDL-C (P = 0.001). However, the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05). No adverse effect was observed.

Conclusions

The N. sativa seed oil seems to be safe and improve liver steatosis and injury and blood levels of triglycerides, LDL-C and HDL-C in the NAFLD patients.

Research Insights

Black Caraway→Increased HDL Cholesterol Levels
9.5 ± 7.7 and 4.8 ± 6.5% for HDL-C (P = 0.001)
Effect
Beneficial
Effect size
Small
Dose
2.5 mL every 12 h
Black Caraway→Reduced Alanine Aminotransferase Level
Mean ± standard deviation of changes of variables in the oil and placebo groups were respectively 32.6 ± 16.6 and 14.2 ± 19.7% for ALT (P < 0/001)
Effect
Beneficial
Effect size
Moderate
Dose
2.5 mL every 12 h
Black Caraway→Reduced Aspartate Aminotransferase Level
29.4 ± 16.3 and 12.3 ± 16.8% for AST (P < 0.001)
Effect
Beneficial
Effect size
Moderate
Dose
2.5 mL every 12 h
Black Caraway→Reduced Blood Urea Nitrogen Levels
the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05)
Effect
Neutral
Effect size
Small
Dose
2.5 mL every 12 h
Black Caraway→Reduced Body Mass Index
the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05)
Effect
Neutral
Effect size
Small
Dose
2.5 mL every 12 h
Black Caraway→Reduced Creatinine Level
the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05)
Effect
Neutral
Effect size
Small
Dose
2.5 mL every 12 h
Black Caraway→Reduced Hepatic Steatosis Grade
Grade of hepatic steatosis was significantly reduced in the oil group compared to the placebo group (P = 0.004).
Effect
Beneficial
Effect size
Moderate
Dose
2.5 mL every 12 h
Black Caraway→Reduced Low-Density Lipoprotein Level
14.1 ± 9.8 and 9.2 ± 11.1% for LDL-C (P = 0.01)
Effect
Beneficial
Effect size
Small
Dose
2.5 mL every 12 h
Black Caraway→Reduced Triglyceride Levels
10 ± 13.9 and 0.22 ± 18.2% for triglycerides (P = 0.001)
Effect
Beneficial
Effect size
Moderate
Dose
2.5 mL every 12 h

Adverse Events Reported

Black Caraway→blood urea nitrogen
However, the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05).
Finding
No significant difference
Significant
No
Black Caraway→complete blood cell count
However, the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05).
Finding
No significant difference
Significant
No
Black Caraway→creatinine
However, the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05).
Finding
No significant difference
Significant
No
Black Caraway→Overall tolerability
No adverse effect was observed.
Finding
Reported