Aim

This study aimed at evaluating the effect of Nigella sativa (NS) on anthropometric, metabolic and inflammatory parameters and examining its related molecular mechanisms in obese prediabetic individuals as compared to both lifestyle modification (LM) and Metformin (Met).

Methods

This study included 117 obese prediabetic subjects who were randomized into LM group which followed controlled diet and exercise regimen, metformin group received metformin 500 mg tablets twice daily and NS group received NS oil soft gelatin capsules 450 mg twice daily. Anthropometric (weight, BMI), glycemic, lipid, inflammatory parameters and genetic expressions of Sirtuin-1 (SIRT1) and p53 genes were assessed before and six months after interventions.

Results

Post-intervention pairwise comparison revealed that, NS was statistically similar to metformin in improving anthropometric, glycemic parameters and SIRT1 gene expression. There was non-significant difference between LM and NS regarding their effects on anthropometric and most of glycemic parameters. Lifestyle modification group showed significantly higher HOMA-B and SIRT1 expression than NS and metformin. Nigella sativa improved lipid panel and significantly reduced TNF-α level and Castelli risk index-I as compared to other interventions.

Conclusion

Nigella sativa uniquely improved lipid panel and significantly suppressed inflammation. Therefore, Nigella sativa may represent a promising intervention for obese prediabetic subjects.

Clinicaltrial.gov ID: NCT03925714.

中文翻译：

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Nigella sativa 作为肥胖前驱糖尿病受试者代谢和炎症性疾病的一种有希望的干预措施：Nigella sativa 与生活方式改变和二甲双胍的比较研究

目标

本研究旨在评估Nigella sativa (NS) 对人体测量学、代谢和炎症参数的影响，并与生活方式改变 (LM) 和二甲双胍 (Met) 相比，检查其在肥胖前驱糖尿病个体中的相关分子机制。

方法

本研究包括 117 名肥胖的糖尿病前期受试者，随机分为 LM 组，遵循控制饮食和运动方案，二甲双胍组接受二甲双胍 500 mg 片剂，每日两次，NS 组接受 NS 油软明胶胶囊 450 mg，每日两次。在干预前和干预后六个月评估人体测量学（体重、BMI）、血糖、血脂、炎症参数和 Sirtuin-1 (SIRT1) 和 p53 基因的基因表达。

结果

干预后成对比较显示，NS 在改善人体测量、血糖参数和 SIRT1 基因表达方面与二甲双胍在统计学上相似。LM 和 NS 对人体测量和大多数血糖参数的影响没有显着差异。生活方式改变组的 HOMA-B 和 SIRT1 表达显着高于 NS 和二甲双胍。与其他干预措施相比， Nigella sativa改善了脂质面板并显着降低了 TNF-α 水平和 Castelli 风险指数-I。

结论

Nigella sativa独特地改善了脂质面板并显着抑制了炎症。因此，Nigella sativa可能代表肥胖前驱糖尿病受试者的有希望的干预措施。

Clinicaltrial.gov ID：NCT03925714。