Cardioprotective Effect of Nigella sativa in Pediatric Patients with Type 1 Diabetes Mellitus: A Randomized Controlled Study
What this study found
Nigella sativa seed oil appeared to improve subclinical left ventricular dysfunction and several cardiometabolic and inflammatory markers, while glycemic measures did not differ meaningfully. After 3 months, the active group showed better between-group values for cholesterol (153 ± 13.5 vs 163 ± 17.4; p = 0.024), LDL-C (78.9 ± 9.8 vs 89.4 ± 11.5; p < 0.001), MDA (3.8 ± 0.9 vs 4.74 ± 1.16; p < 0.001), nitric oxide (40.5 ± 3.7 vs 49 ± 4; p < 0.001), TNF-α (8.5 ± 2.4 vs 10.3 ± 2.9; p = 0.009), TGF-β (7.4 ± 2.5 vs 8.9 ± 2.94; p = 0.02), and troponin I (0.04 ± 0.02 vs 0.061 ± 0.02; p = 0.002).…
- Study & population
- Randomized controlled study in pediatric patients with type 1 diabetes mellitus from the pediatric endocrinology outpatient clinic of Tanta University hospitals in Egypt.
- Intervention
- Nigella sativa seed oil (Baraka; Pharco Pharmaceuticals, Cairo, Egypt) was given at 450 mg twice daily after meals for 3 months, added to insulin therapy.
- Key limitation
- The study was small, with only 30 participants per active arm, and was conducted at a single center.
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Open PDFOriginal abstract
Nigella sativa is a widely used medicinal plant with several potential therapeutic uses. This study aimed to investigate the possible beneficial cardioprotective effect of Nigella sativa in pediatric patients with type 1 diabetes mellitus. Sixty children and adolescents with type 1 diabetes were randomized into two groups: group I (n = 30) who received Nigella sativa seed oil 450 mg twice daily after meals for 3 months in addition to insulin, and group II (n = 30) who received insulin alone. Echocardiographic examinations were performed before and after the treatment. The lipid profile, malondialdehyde, nitric oxide, tumor necrosis factor-α, transforming growth factor-β, and troponin I were also measured before and after Nigella sativa treatment. After 3 months of Nigella sativa administration, group I had significantly lower cholesterol and low-density lipoprotein-cholesterol, malondialdehyde, nitric oxide, tumor necrosis factor-α, transforming growth factor-β, and troponin I levels compared with their pretreatment levels and compared with group II. In addition, group I had a significantly higher left ventricular E′/A′ ratio and two-dimensional left ventricular global longitudinal strain (2D-LV GLS) compared with baseline values and compared with group II after treatment. Nigella sativa can improve subclinical left ventricular dysfunction in pediatric patients with type 1 diabetes mellitus. Clinical Trial Registration: this clinical trial was registered at www.pactr.org with ID: PACTR202302478939306.