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Introduction: 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. Methods: 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). Results: 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). Discussion: 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. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT05267301.
RESUMO
BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has disrupted medical care across diverse populations with varying outcomes. In this study, we evaluated the relationship between health rating and disruption in medical care due to COVID-19 among individuals with atherosclerotic cardiovascular disease (ASCVD). METHODS: Data from the 2020 National Health Interview Survey was used for this study. ASCVD sample included those with self-reported coronary heart disease, stroke, and heart attack. Health rating was represented as fair to poor, good, and very good to excellent. The outcome variable was a disruption of medical care due to COVID-19 (delay in medical care or did not get care). The chi-square test was used for the descriptive analysis and multiple logistic regression was used to evaluate the relationship between health rating and disruption in medical care with demographic factors, comorbidities, and cumulative social risk adjusted for. RESULTS: Among the 31,568 adults, 1,707/31,568 representing 9,385,855 adults 18 years and above with ASCVD reported experiencing or not experiencing a disruption in medical care. After adjusting for cumulative risk, the odds of not getting medical care due to COVID-19 were high for those who rated their health as fair/poor as compared to excellent (adjusted odds ratio (AOR) = 1.95, 95% CI = 1.24-3.08, p = 0.004). These odds remained about the same after adjusting for cumulative social risk, demographic factors, and comorbidities (AOR = 1.84, 95% CI = 1.11-3.06, p = 0.018). After adjusting for cumulative risk, medical care utilization (received, delayed, did not receive) was rated. Those who rated their health as fair to poor as compared to excellent were more likely to report a delay in health care due to COVID-19 (AOR = 1.85, 95% CI = 1.28-2.68, p = 0.001) and remained about the same after adjusting for cumulative social risk, demographic factors, and comorbidities (AOR = 1.86, 95% CI = 1.22-2.82, p = 0.004). Female respondents with ASCVD who rated their health as fair/poor were more likely to experience a delay in medical care due to COVID-19 (AOR = 2.06, 95% CI = 1.06-4.01, p = 0.033) or not get medical care due to COVID-19 (AOR = 2.86, 95% CI = 1.42-5.76, p = 0.003) as compared to those who rated their health as excellent. With regards to men with ASCVD, health rating was not related to their reported disruption of medical care due to COVID-19. CONCLUSIONS: A poor to fair health rating is associated with a delay in getting or not getting medical care among individuals with ASCVD. Further studies are needed to evaluate this relationship further.
