Smyth Andrew, Judge Conor, Kerins Claire, McDermott Suzanne, Niland Aoife, Corcoran Colette, Dineen Roisin, Alvarez-Iglesias Alberto, Nolan Aoife, Mente Andrew, Griffin Matthew D, O'Shea Paula, Canavan Michelle, Yusuf Salim, O'Donnell Martin
HRB Clinical Research Facility Galway, College of Medicine, Nursing and Health Sciences, University of Galway, Ireland.
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
EClinicalMedicine. 2023 Feb 15;57:101856. doi: 10.1016/j.eclinm.2023.101856. eCollection 2023 Mar.
While low sodium intake (<2.3 g/day) is recommended, there is uncertainty about long-term feasibility and effects on cardiorenal biomarkers in populations with moderate intake.
In two phase IIb, feasibility, randomised, parallel, open-label, controlled, single-centre trials, individuals aged >40 years with stable blood pressure (BP), without heart failure or postural hypotension were randomised to intensive dietary counselling (target sodium intake <2.3 g/day) or usual care between March 2016 and July 2018. One trial included participants with chronic kidney disease (CKD); the other excluded those with CKD or cardiovascular disease. All participants received healthy eating advice. Primary outcomes were NT-pro B-type natriuretic peptide (NT-proBNP), high sensitivity troponin T (hsTnT), C-reactive protein (CRP), renin, aldosterone and, creatinine clearance (CrCl) at 2-years. These trials are registered with ClinicalTrials.gov, STICK trial (NCT02458248) and COSIP trial (NCT02738736).
373 participants, with mean 24-h urine sodium 3.16 ± 1.47 g/day, were randomised to intervention (n = 187) or usual care (n = 186). At 3-months, the intervention reduced 24-h urine sodium (intervention -0.11 g/day, usual care +0.28 g/day, p = 0.003), BP (systolic -2.52 mmHg, p = 0.05; diastolic -1.92, p = 0.02) and increased renin (+33.35 mIU/L [95%CI 3.78-62.91]). At 2-years, the intervention significantly reduced self-reported salt use (p < 0.001), but not 24-h urine sodium (intervention -0.23 g/day, usual care +0.05 g/day, p = 0.47). At 2-years, there were no significant between-group differences in BP (systolic p = 0.66; diastolic p = 0.09), NT-proBNP (p = 0.68), hsTnT (p = 0.20), CRP (p = 0.56), renin (p = 0.52), aldosterone (p = 0.61), or CrCl (p = 0.68).
Among individuals with moderate sodium intake, intensive dietary counselling resulted in small short-term reductions in sodium intake and BP, but no significant effect on sodium intake, BP, or cardiorenal biomarkers at two years. Our trial suggests that it may not feasible to reduce sodium sustainably in those with a sodium intake around 3.0 g/day, through an intensive dietary counselling intervention.
The STICK trial was funded by the Health Research Board of Ireland and the COSIP trial was funded by the European Research Council.
虽然推荐低钠摄入（<2.3克/天），但对于中等摄入量人群的长期可行性及其对心脏和肾脏生物标志物的影响尚不确定。
在两项IIb期、可行性、随机、平行、开放标签、对照、单中心试验中，将年龄>40岁、血压稳定（BP）、无心力衰竭或体位性低血压的个体在2016年3月至2018年7月期间随机分为强化饮食咨询组（目标钠摄入量<2.3克/天）或常规护理组。一项试验纳入了慢性肾脏病（CKD）患者；另一项试验排除了患有CKD或心血管疾病的患者。所有参与者均接受健康饮食建议。主要结局指标为2年时的N末端B型利钠肽原（NT-proBNP）、高敏肌钙蛋白T（hsTnT）、C反应蛋白（CRP）、肾素、醛固酮和肌酐清除率（CrCl）。这些试验已在ClinicalTrials.gov注册，即STICK试验（NCT02458248）和COSIP试验（NCT02738736）。
373名参与者，平均24小时尿钠为3.16±1.47克/天，被随机分为干预组（n = 187）或常规护理组（n = 186）。在3个月时，干预组降低了24小时尿钠（干预组-0.11克/天，常规护理组+0.28克/天，p = 0.003）、血压（收缩压-2.52 mmHg，p = 0.05；舒张压-1.92，p = 0.02）并增加了肾素（+33.35 mIU/L [95%CI 3.78 - 62.91]）。在2年时，干预组显著减少了自我报告的盐摄入量（p < 0.001），但24小时尿钠没有减少（干预组-0.23克/天，常规护理组+0.05克/天，p = 0.47）。在2年时，两组之间在血压（收缩压p = 0.66；舒张压p = 0.09）、NT-proBNP（p = 0.68）、hsTnT（p = 0.20）、CRP（p = 0.56）、肾素（p = 0.52）、醛固酮（p = 0.61）或CrCl（p = 0.68）方面没有显著差异。
在中等钠摄入量的个体中，强化饮食咨询在短期内使钠摄入量和血压有小幅降低，但在两年时对钠摄入量、血压或心脏和肾脏生物标志物没有显著影响。我们的试验表明，通过强化饮食咨询干预，对于钠摄入量约为3.0克/天的人群，持续降低钠摄入量可能不可行。
STICK试验由爱尔兰健康研究委员会资助，COSIP试验由欧洲研究理事会资助。
