Pingali Usharani, Nutalapati Chandrasekhar, Illendulla Vijay Sravanthi
Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, 500082, India.
Govt. Ayurvedic Dispensary, Primary Health Center Gummadidala, Sangareddy, Telangana, 502313, India.
Diabetes Metab Syndr Obes. 2020 Jan 7;13:31-42. doi: 10.2147/DMSO.S220046. eCollection 2020.
This study was conducted to evaluate the effectiveness of fish oil alone and with an adjunct, a proprietary chromium complex (PCC), on cardiovascular parameters - endothelial dysfunction, lipid profile, systemic inflammation and glycosylated hemoglobin - in a 12-week randomized, double-blind, placebo-controlled clinical study in type 2 diabetes mellitus subjects.
In this randomized, double-blind, parallel group study, 59 subjects in three groups completed the study: Group A, fish oil 2000 mg; Group B, fish oil 2000 mg + PCC 10 mg (200 µg of Cr); and Group C, fish oil 2000 mg + PCC 20 mg (400 µg of Cr) daily for 12 weeks (2000 mg of fish oil contained 600 mg of eicosapentaenoic acid [EPA] and 400 mg of docosahexaenoic acid [DHA], the omega-3 fatty acids). Endothelial function, by estimating reflection index (RI), biomarkers of oxidative stress (nitric oxide [NO], malondialdehyde [MDA], glutathione [GSH]) and inflammatory biomarkers (high-sensitivity C-reactive protein [hsCRP], intercellular adhesion molecule-1 [ICAM-1], vascular cell adhesion molecule-1 [VCAM-1], endothelin-1) were evaluated at baseline, and 4 and 12 weeks. Lipid profile, platelet aggregation and glycosylated hemoglobin [HbA1c) were tested at baseline and 12 weeks. Any reported adverse drug reactions were recorded. Statistical analysis was performed using GraphPad Prism 8.
The present study shows that fish oil by itself, at a dose of 2000 mg (600 mg of EPA + 400 mg of DHA) per day, led to significant, but only modest, improvement in cardiovascular parameters (RI from -2.38±0.75 to -3.92±0.60, MDA from 3.77±0.16 to 3.74±0.16 nM/mL, NO from 30.60±3.18 to 32.12±3.40 µM/L, GSH from 568.93±5.91 to 583.95±6.53 µM/L; p≤0.0001), including triglyceride levels. However, when PCC was added to fish oil, especially at the 20 mg dose, there were highly significant improvements in all the parameters tested (RI from -2.04±0.79 to -8.73±1.36, MDA from 3.67±0.39 to 2.89±0.34 nM/mL, NO from 28.98±2.93 to 40.01±2.53 µM/L, GSH from 553.82±8.18 to 677.99±10.19 µM/L; p≤0.0001), including the lipid profile. It is noteworthy that the triglycerides were decreased significantly by addition of 20 mg of PCC although the dose of fish oil was only 2 g/day and the baseline triglyceride levels were only about 200 mg/dL. Fish oil alone did not significantly decrease the HbA1c, whereas the addition of 20 mg of PCC did.
Addition of PCC, especially at 20 mg dose, significantly improves the efficacy of fish oil in addressing cardiovascular risk factors compared to fish oil given alone.
本研究旨在通过一项为期12周的随机、双盲、安慰剂对照临床研究，评估单独使用鱼油以及联合一种专利铬复合物（PCC）对2型糖尿病患者心血管参数（内皮功能障碍、血脂谱、全身炎症和糖化血红蛋白）的有效性。
在这项随机、双盲、平行组研究中，三组共59名受试者完成了研究：A组，每日服用2000毫克鱼油；B组，每日服用2000毫克鱼油+10毫克PCC（含200微克铬）；C组，每日服用2000毫克鱼油+20毫克PCC（含400微克铬），持续12周（2000毫克鱼油含600毫克二十碳五烯酸[EPA]和400毫克二十二碳六烯酸[DHA]，即ω-3脂肪酸）。在基线、第4周和第12周评估内皮功能（通过估算反射指数[RI]）、氧化应激生物标志物（一氧化氮[NO]、丙二醛[MDA]、谷胱甘肽[GSH]）和炎症生物标志物（高敏C反应蛋白[hsCRP]、细胞间黏附分子-1[ICAM-1]、血管细胞黏附分子-1[VCAM-1]、内皮素-1）。在基线和第12周检测血脂谱、血小板聚集和糖化血红蛋白[HbA1c]。记录所有报告的药物不良反应。使用GraphPad Prism 8进行统计分析。
本研究表明，每日服用2000毫克（600毫克EPA+400毫克DHA）的鱼油本身可使心血管参数（RI从-2.38±0.75改善至-3.92±0.60，MDA从3.77±0.16降至3.74±0.16纳摩尔/毫升，NO从30.60±3.18升至32.12±3.40微摩尔/升，GSH从568.93±5.91升至583.95±6.53微摩尔/升；p≤0.0001）有显著但仅为适度的改善，包括甘油三酯水平。然而，当PCC添加到鱼油中时，尤其是20毫克剂量时，所有测试参数（RI从-2.04±0.79改善至-8.73±1.36，MDA从3.67±0.39降至2.89±0.34纳摩尔/毫升，NO从28.98±2.93升至40.01±2.53微摩尔/升，GSH从553.82±8.18升至677.99±10.19微摩尔/升；p≤0.0001）都有高度显著的改善，包括血脂谱。值得注意的是，尽管鱼油剂量仅为每日2克且基线甘油三酯水平仅约为200毫克/分升，但添加20毫克PCC可使甘油三酯显著降低。单独使用鱼油并未显著降低HbA1c，而添加20毫克PCC则有此效果。
与单独使用鱼油相比，添加PCC，尤其是20毫克剂量，可显著提高鱼油在解决心血管危险因素方面的疗效。
