de Abreu-Silva Erlon Oliveira, Machado Rachel Helena Vieira, Dos Santos Bianca Rodrigues, Kojima Flávia Cristina Soares, Santos Renato Hideo Nakagawa, Negrelli Karina do Lago, Rodrigues Letícia Barbante, de Barros E Silva Pedro Gabriel Melo, de Lima Andressa Gusmão, Sanchez João Gabriel, El Khouri Fernanda Jafet, Bersch-Ferreira Ângela Cristine, Carvalho Adriana Bastos, de Oliveira Thaís Martins, Izar Maria Cristina, Sampaio Geni Rodrigues, Damasceno Nágila Raquel Teixeira, Rogero Marcelo Macedo, Torres Elizabeth Aparecida Ferraz da Silva, Cartolano Flávia De Conti, Krey Julia Pinheiro, de Luca Patrícia Vieira, Amaral Cristiane Kovacs, Dos Santos Elisa Maia, de Melo Rodrigo Morel Vieira, Lima Eduardo Gomes, Dos Santos André de Luca, Heck Thiago Gomes, Carvalho Ana Paula Perillo Ferreira, Garofallo Silvia Bueno, Cavalcanti Alexandre Biasi, Marcadenti Aline
Hcor Research Institute, São Paulo 04004-030, SP, Brazil.
Division of Health Care Sciences, Dresden International University, 01307 Dresden, Germany.
Nutrients. 2025 Jun 15;17(12):2008. doi: 10.3390/nu17122008.
Familial hypercholesterolemia (FH) is an increasingly common inherited disorder that increases cardiovascular risk. Despite the importance of lifestyle interventions, adherence to a healthy diet among individuals with FH remains suboptimal. This pilot, multicenter, double-blind, placebo-controlled randomized trial aimed to evaluate the feasibility and preliminary effects of a culturally adapted cardioprotective diet (DICA-FH), alone or in combination with phytosterol and/or krill oil supplementation, on lipid parameters in Brazilian adults with probable or definitive FH. Between May and August 2023, 58 participants were enrolled across nine Brazilian centers and randomized (1:1:1:1) into four groups: DICA-FH + phytosterol placebo + krill oil placebo; DICA-FH + phytosterol 2 g/day + krill oil placebo; DICA-FH + phytosterol placebo + krill oil 2 g/day; and DICA-FH + phytosterol 2 g/day + krill oil 2 g/day. Interventions lasted 120 days. The primary outcomes were mean low-density lipoprotein cholesterol (LDL-c) and lipoprotein(a) (Lp[a]) levels, as well as adherence to treatment at follow-up. Secondary outcomes included mean levels of other lipids, frequency of adverse events, and assessment of protocol implementation components. All data were presented separately for the allocation groups: phytosterol vs. placebo and krill oil vs. placebo. Mean age was 54.5 ± 13.7 years, and 58.6% were women. Both adherence to protocol (91.8% attendance; 79.1% investigational product intake) and retention (86.2%) were high. No significant differences between groups were found for LDL-c or Lp(a). However, regardless of allocation to active supplementation or placebo, a significant reduction in Lp(a) concentrations was observed following the DICA-FH intervention (median difference: -3.8 mg/dL [interquartile range: -7.5 to -1.2]; < 0.01). Significant reductions in oxidized LDL (LDL-ox) and LDL-ox/LDL-c ratio were also observed in the overall sample ( < 0.01). Although not statistically significant, all groups showed improvements in diet quality after 120 days. No serious adverse events related to the interventions were reported. Additionally, most protocol implementation components were successfully achieved. The DICA-FH strategy, with or without supplementation, was safe and well-tolerated. Although not powered to detect clinical efficacy (which is acceptable in exploratory pilot trials), the study supports the feasibility of a larger trial and highlights the potential of dietary interventions in the management of HF.
家族性高胆固醇血症(FH)是一种日益常见的遗传性疾病,会增加心血管疾病风险。尽管生活方式干预很重要,但FH患者对健康饮食的依从性仍不理想。这项试点、多中心、双盲、安慰剂对照的随机试验旨在评估一种根据文化调整的心脏保护饮食(DICA-FH)单独使用或与植物甾醇和/或磷虾油补充剂联合使用,对巴西可能患有或确诊患有FH的成年人血脂参数的可行性和初步效果。在2023年5月至8月期间,巴西九个中心招募了58名参与者,并将其随机(1:1:1:1)分为四组:DICA-FH + 植物甾醇安慰剂 + 磷虾油安慰剂;DICA-FH + 植物甾醇2克/天 + 磷虾油安慰剂;DICA-FH + 植物甾醇安慰剂 + 磷虾油2克/天;以及DICA-FH + 植物甾醇2克/天 + 磷虾油2克/天。干预持续120天。主要结局是平均低密度脂蛋白胆固醇(LDL-c)和脂蛋白(a)(Lp[a])水平,以及随访时的治疗依从性。次要结局包括其他血脂的平均水平、不良事件的发生率以及方案实施组成部分的评估。所有数据按分配组分别呈现:植物甾醇与安慰剂以及磷虾油与安慰剂。平均年龄为54.5±13.7岁,女性占58.6%。方案依从性(91.8%的出勤率;79.1%的研究产品摄入量)和保留率(86.2%)都很高。各小组之间在LDL-c或Lp(a)方面未发现显著差异。然而,无论分配到活性补充剂还是安慰剂组,在DICA-FH干预后,Lp(a)浓度均显著降低(中位数差异:-3.8毫克/分升[四分位间距:-7.5至-1.2];P<0.01)。在总体样本中,氧化型LDL(LDL-ox)和LDL-ox/LDL-c比值也显著降低(P<0.01)。虽然无统计学意义,但所有组在120天后饮食质量均有所改善。未报告与干预相关的严重不良事件。此外,大多数方案实施组成部分都成功实现。DICA-FH策略,无论是否补充,都是安全且耐受性良好的。尽管该研究没有足够的效力来检测临床疗效(这在探索性试点试验中是可以接受的),但该研究支持了进行更大规模试验的可行性,并突出了饮食干预在HF管理中的潜力。
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