■AlmegaPL®是一种富含极性脂质(>15%w/w)的油,来自微藻纳米绿藻,仅包含二十碳五烯酸(EPA>25%w/w),没有存在于所有其他天然来源的omega-3中的DHA。先前的一项随机对照临床试验发现证明了AlmegaPL®补充剂降低胆固醇水平的能力。
■在这项上市后队列研究中,我们基于先前的发现,并针对补充的实际最终用户。参与者从AlmegaPL®胶囊(1000-1100mg/天)的新订户数据库中招募,以捕获现实世界临床和消费者设置的复杂性。循环甘油三酯(TG)的变化,残余胆固醇(RC),低密度脂蛋白胆固醇(LDL),高密度脂蛋白胆固醇(HDL),总胆固醇(TC),高敏C反应蛋白(hs-CRP),血糖和糖化血红蛋白(HbA1c)在基线监测,使用Imaware®的在家基线心脏健康检测试剂盒进行补充的第3个月和第6个月(休斯顿,TX,美国)。
■参与者,谁有,平均而言,正常的TG水平在基线(1.62±0.60mmol/L),在第3个月(8.0%;-0.13±0.59mmol/L;p<0.001)和第6个月(14.2%;-0.23±0.64mmol/L;p<0.001)(主要结局)时,TG出现了显著且进行性的下降.此外,经过6个月的补充,TC和非HDL-胆固醇分别降低了5.0%(-0.26±0.98mmol/L;p<0.001)和5.5%(-0.21±0.86mmol/L;p<0.001),主要由RC降低14.9%(-0.11±0.29mmol/L;p<0.001)驱动。
■与我们之前的临床试验一致,RC的减少与LDL的增加无关,这似乎是与仅基于EPA的制剂相关的益处。此外,这项研究证明了AlmegaPL®通过进一步诱导14.9%的降低来维持已经健康的TG水平的能力。总的来说,这些发现强调了AlmegaPL®的独特性,它是仅用于EPA的极性脂质的天然非处方选择,在维持总体健康的血脂水平方面显得特别有效,血脂正常的人群。
■https://clinicaltrials.gov/,标识符NCT05267301。
UNASSIGNED: AlmegaPL® is an oil rich in polar-lipid (> 15% w/w) derived from the microalga Nannochloropsis, that contains exclusively eicosapentaenoic acid (EPA > 25% w/w), without the DHA that is present in all other natural sources of omega-3. Previous findings from a randomized controlled clinical trial demonstrated the ability of AlmegaPL® supplementation to reduce cholesterol levels.
UNASSIGNED: In this post-market cohort study, we built upon previous findings and targeted the actual end-users of the supplement. Participants were recruited from a new subscriber database of AlmegaPL® capsules (1000-1100 mg/day) to capture the complexity of real-world clinical and consumer settings. Changes in circulating triglycerides (TG), remnant cholesterol (RC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), total cholesterol (TC), high-sensitivity C-reactive protein (hs-CRP), glucose and glycated hemoglobin (HbA1c) were monitored at baseline, Month 3, and Month 6 of supplementation using the at-home Baseline Heart Health Testing Kit by Imaware® (Houston, TX, USA).
UNASSIGNED: Participants, who had, on average, normal TG level at baseline (1.62 ± 0.60 mmol/L), experienced a significant and progressive decrease in TG at Month 3 (8.0%; -0.13 ± 0.59 mmol/L; p < 0.001) and Month 6 (14.2%; -0.23 ± 0.64 mmol/L; p < 0.001) (primary outcome). Furthermore, after 6 months of supplementation, TC and non-HDL-cholesterol decreased by 5.0% (-0.26 ± 0.98 mmol/L; p < 0.001) and 5.5% (-0.21 ± 0.86 mmol/L; p < 0.001) respectively, primarily driven by a 14.9% reduction in RC (-0.11 ± 0.29 mmol/L; p < 0.001).
UNASSIGNED: Consistent with our previous clinical trial, the decrease in RC was not coupled to an increase in LDL, which seems to be a benefit associated with EPA-only based formulations. In addition, this study demonstrated the AlmegaPL® capacity to maintain already healthy TG levels by further inducing a 14.9% decrease. Collectively, these findings highlight AlmegaPL® uniqueness as a natural over-the-counter option for EPA-only polar lipid that appears particularly effective in maintaining blood lipid levels in a generally healthy, normolipidemic population.
UNASSIGNED: https://clinicaltrials.gov/, identifier NCT05267301.