《一项磷虾油对2型糖尿病患者的内皮细胞功能和心血管风险因素的影响的随机对照试验》Lobraico JM, DiLello LC et al.BMJ Open Diabetes Res Care. 2015 Oct 14;3(1):e000107.|中冠生物科技(珲春)有限公司 

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《一项磷虾油对2型糖尿病患者的内皮细胞功能和心血管风险因素的影响的随机对照试验》

Lobraico JM, DiLello LC et al.BMJ Open Diabetes Res Care. 2015 Oct 14;3(1):e000107.

摘要:
目的:

本试验旨在评估补充磷虾油来源的ω-3脂肪酸对2型糖尿病参与者心血管疾病危险因素和血糖控制的影响。
研究设计与方法:
采用随机双盲对照交叉试验。评估结果包括:内皮功能、血脂、血糖、糖化血红蛋白、血清抗氧化水平、C肽和胰岛素抵抗(HOMA-IR)评分的稳态模型。受试者被随机分配补充磷虾油或橄榄油,连续补充4周,经过2周的洗脱期后,再交叉补充另一种补充剂4周。然后,所有受试者再补充17周的磷虾油。测试发生在3个时间点:基线、第一次补充后和第二次补充后。试验也可选在连续补充磷虾油17周后。计算两个序列中每个参与者的差异分数(即序列第一和第二阶段的结果测量差异)。用两个序列组的平均分和标准差检验治疗效果的差异,显著性水平p<0.05。
结果:
初步交叉研究共包括47名参与者。与橄榄油相比,接受磷虾油4周的受试者的内皮功能有所改善, C肽水平和HOMA评分也有所降低。共有34名参与者完成了额外的17周补充期。当与各自的基线测量值进行比较时,这些参与者的内皮功能和血液中的高密度脂蛋白(HDL)有统计学上的显著改善。
结论:
磷虾油可以适度改善心血管风险病风险,特别是2型糖尿病患者的内皮功能障碍和高密度脂蛋白(HDL)。
临床注册号:NCT0209191193

Abstract:
Objective: 

The purpose of this trial was to evaluate the effect of krill oil supplementation, a source of ω-3 fatty acids, on cardiovascular disease risk factors and blood glucose control among participants with type 2 diabetes.
RESEARCH DESIGN AND METHODS: 
A randomized, double-blind controlled cross-over trial was employed. Outcomes assessed were: endothelial function, blood lipids, glucose, glycated hemoglobin, serum antioxidant level, C peptide, and calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) scores. Participants were randomized to either krill oil or olive oil supplementation for 4 weeks, underwent a 2-week washout period, and then crossed to the other supplementation for 4 weeks. All participants were then offered an additional 17 weeks of krill supplementation. Testing occurred at 3 time points: baseline, after first supplementation, and after second supplementation. Testing also occurred after an optional 17 weeks of krill oil supplementation. Difference scores were calculated for each participant in both sequences (ie, differences in outcome measures in the first and second period of the sequence). The mean and SD of the scores in the 2 sequence groups were used to test for differences between treatment effects at a significance level of p<0.05.
Results: 
A total of 47 participants were included in the initial cross-over study. Participants who received krill oil for 4 weeks had an improvement in their endothelial function and a reduction in blood C peptide levels and HOMA scores as compared with the olive oil. A total of 34 participants completed the additional 17-week supplementation period. When compared with their respective baseline measures, these participants had a statistically significant improvement in endothelial function and blood high-density lipoprotein (HDL).
Conclusions: 
Krill oil may lead to moderate improvement of cardiovascular risks, specifically endothelial dysfunction and HDL in patients with type 2 diabetes.
TRIAL REGISTRATION NUMBER: 
Registered with ClinicalTrials.gov: NCT02091193.