Pingali Usharani, Nutalapati Chandrasekhar, Gundagani Srinivas
Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad 500082, Telangana, India.
Evid Based Complement Alternat Med. 2021 Jun 25;2021:2972610. doi: 10.1155/2021/2972610. eCollection 2021.
Metabolic syndrome (MetS) represents a cluster of metabolic abnormalities that include hypertension, central obesity, insulin resistance, and dyslipidemia and is strongly associated with an increased risk of diabetes, cardiovascular diseases (CVD), and all-cause mortality. Early diagnosis is important to employ lifestyle and risk factor modification. Existing therapies are limited. Studies report positive effect of omega-3 fatty acids (-3FA) on symptoms of metabolic syndrome. The present study was undertaken to evaluate the effect of -3FA alone and in combination with proprietary chromium complex (PCC) on endothelial function in subjects with metabolic syndrome. In this randomized, double-blind, parallel-group study, subjects were enrolled into the study after ethics committee (EC) approval and informed consent. Eligible subjects were randomized to receive -3FA concentrate 2000 mg (Group A-18 subjects), -3FA concentrate 2000 mg + PCC200 mcg (Group B-19 subjects), and -3FA concentrate 2000 mg + PCC400 mcg (Group C-21 subjects) daily for 12 weeks. Endothelial dysfunction as measured by reflection index (RI), biomarkers of oxidative stress (NO, MDA, and glutathione), and inflammation (hsCRP, endothelin-1, ICAM-1, and VCAM-1) were evaluated at baseline, 4, and 12 weeks. Lipid-profile and platelet-aggregation tests were performed at baseline and 12 weeks. Adverse drug reactions were recorded. Compliance was assessed by pill count method. GraphPad Prism8 was used for statistical analysis. Significant changes were seen from 4 weeks onwards in all the parameters evaluated. Significant improvement in RI% (mean ± SD = -2.56 ± 0.77 to -3.27 ± 0.67-group A, -2.33 ± 0.76 to 4.72 ± 0.79-group B; -2.39 ± 1.13 to 6.46 ± 1.00-group C) was seen at 12 weeks. Significant improvement in biomarkers of oxidative stress and inflammation was seen with all the treatment groups. Similarly, significant improvement in lipid profile was seen in group B and group C, while group A showed change in HDL, VLDL, and TG. Group C demonstrated the best response in the parameters evaluated. Three patients in group C reported gastrointestinal adverse events, which resolved spontaneously; none stopped the therapy. So, the addition of PCC to -3FA may prove to have beneficial effect in reducing cardiovascular morbidity in MetS patients.
代谢综合征（MetS）是一组代谢异常，包括高血压、中心性肥胖、胰岛素抵抗和血脂异常，与糖尿病、心血管疾病（CVD）风险增加及全因死亡率密切相关。早期诊断对于采取生活方式调整和风险因素干预很重要。现有治疗方法有限。研究报告称ω-3脂肪酸（-3FA）对代谢综合征症状有积极作用。本研究旨在评估-3FA单独使用以及与专利铬复合物（PCC）联合使用对代谢综合征患者内皮功能的影响。在这项随机、双盲、平行组研究中，受试者经伦理委员会（EC）批准并签署知情同意书后纳入研究。符合条件的受试者被随机分为三组，分别每日服用2000毫克-3FA浓缩物（A组-18名受试者）、2000毫克-3FA浓缩物+200微克PCC（B组-19名受试者）和2000毫克-3FA浓缩物+400微克PCC（C组-21名受试者），持续12周。在基线、第4周和第12周评估通过反射指数（RI）测量的内皮功能障碍、氧化应激生物标志物（NO、MDA和谷胱甘肽）以及炎症生物标志物（hsCRP、内皮素-1、ICAM-1和VCAM-1）。在基线和第12周进行血脂谱和血小板聚集测试。记录药物不良反应。通过药丸计数法评估依从性。使用GraphPad Prism8进行统计分析。从第4周起，所有评估参数均出现显著变化。在第12周时，RI%有显著改善（平均值±标准差=A组从-2.56±0.77至-3.27±0.67；B组从-2.33±0.76至4.72±0.79；C组从-2.39±1.13至6.46±1.00）。所有治疗组的氧化应激和炎症生物标志物均有显著改善。同样，B组和C组的血脂谱有显著改善，而A组的高密度脂蛋白、极低密度脂蛋白和甘油三酯有变化。C组在评估参数中表现出最佳反应。C组有3名患者报告了胃肠道不良事件，这些事件自行缓解；无人停止治疗。因此，在-3FA中添加PCC可能对降低代谢综合征患者的心血管发病率有有益作用。
