Effect of Nigella sativa oil extract on cardiometabolic risk factors in type 2 diabetes: A randomized, double‐blind, placebo‐controlled clinical trial

Abstract

The objective of this study was to determine the effects of Nigella sativa oil extract on cardiometabolic risk factors in people with type 2 diabetes (T2D). A randomized, controlled, clinical trial was conducted on 43 patients with T2D (23 women and 20 men; aged 53.5 ± 7.4 years). The intervention group (N = 23) received two 500-mg per day soft gel capsules containing Nigella sativa oil extract and the control group (N = 20) received two identical placebo soft gel capsules containing sunflower oil per day for the same period, 8 weeks. Pre-and post-intervention cardiometabolic risk factors were measured. Compared with the placebo, the N. sativa oil significantly decreased FBS (p = .03(, HbA1c (p = .001), total cholesterol (p = .04), TG (p = .003), LDL-c (p = .001), BMI (p < .001), waist circumference (p < .001), SBP (p = .001), and DBP (p = .002). HOMA-IR (p = .51) and HDL-c (p = .91) did not change significantly following Nigella sativa supplementation. Nigella sativa oil exerted beneficial effects on glycemic control, serum lipid profile, blood pressure, and body weight among people with T2D. Further long-term trials in the future may help confirm the current therapeutic benefits of Nigella sativa in T2D.

Nigella sativa supplementation improves cardiometabolic indicators in population with prediabetes and type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials

“…Titles and abstracts were examined for all the remaining 633 records, resulting in the exclusion of 572 publications. Next, the full texts for 61 RCTs were checked, and 50 records were excluded for the following reasons: three studies investigated the effects of N. sativa combining with other supplements where the independent effect of N. sativa could not be distinguished ( 31 – 33 ); three studies had non-randomized designs ( 34 – 36 ); one study reported its results in a non-English language ( 37 ); two studies did not have an appropriate control group ( 38 , 39 ); and the 41 remaining publications provided insufficient data and/or did not meet the inclusion criteria. The final quantitative analysis included 11 trials with 666 participants.…”

“…All the included trials had parallel designs and were published between 2012 and 2022. These studies were carried out in Iran ( 19 , 21 , 37 , 41 , 43 , 45 , 46 ), India ( 40 , 44 ), Egypt ( 20 ), and Saudi Arabia ( 42 ). In total, 666 participants (338 interventions and 328 controls) were recruited with the age range between 42.9 ± 3.2 and 56 ± 3.4 years old and the BMI range between 26.79 ± 2.94 and 33.90 ± 2.10 kg/m 2 .…”

“…The dose of N. sativa supplementation ranged from 0.9 to 5 g/day, with the length of follow-up ranging from 2 to 6 months throughout the studies. Of the 11 RCTs, 9 effect sizes administered oil form of the supplement ( 20 , 21 , 37 , 40 , 41 , 43 – 46 ) and the remaining used extracts of N. sativa ( 19 , 42 ) as an investigational product. All the 11 included trials had appropriate controlled designs, and the only difference between the two groups in each study was the N. sativa intervention.…”

The effect of Nigella sativa oil on vascular dysfunction assessed by flow‐mediated dilation and vascular‐related biomarkers in subject with cardiovascular disease risk factors: A randomized controlled trial

“…In previous study, intervention with N. sativa oil for 2 months was able to have beneficial effects on glycemic control, lipid profile, blood pressure and body weight in diabetic patients (Hadi et al, 2021). In another study, 2 months intervention in patients with rheumatoid arthritis increased plasma levels of interleukin‐10 as an anti‐inflammatory cytokine and also showed antioxidant properties (Hadi et al, 2016).…”

Promoting action of vitamin E and black seed oil on reproductive hormones and organ histoarchitecture of Swiss albino mice

“…Overall, the effects of the black seed oil and vitamin E on the reproductive functions could vary depending on the dosages and duration of the treatment. However, most of the human trials of black seed oil also used doses similar to this study (Hadi et al, 2021;Koshak et al, 2021).…”