Allaert François-André
Health Claim Medical Evaluation Chair BSB, Dijon, France -
Minerva Cardioangiol. 2017 Dec;65(6):563-576. doi: 10.23736/S0026-4725.17.04451-6. Epub 2017 Aug 31.
Because of the impressive increase in the risk of cardiovascular complications associated with levels of BP previously considered to be normal, the JNC 7 report has introduced a new classification that includes the term "prehypertension" for those with blood pressures (BPs) ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic. In the framework of a salt reduction as recommended by health authorities, this trial evaluates if the use of Symbiosal® reduces more prehypertension than standard table marine salt (NaCl).
Study design: monocenter, randomized, double blind, controlled trial comparing the marine salt NaCl + Chitosan 3% according a specific patent Symbiosal and the standard table marine salt NaCl. The study has been conducted in 2 parallel arms design: every subject received, according to the randomization Symbiosal or NaCl.
The main objective of this clinical trial was to demonstrate a higher reduction of systolic BP (SBP) with Symbiosal than with NaCl in the framework of a table salt reduction to a maximum of 3 g per day in prehypertensive patients RESULTS: Twenty-two subjects were included in the Symbiosal group and 19 in the NaCl group according randomization. The two groups have the same salt consumption: a daily intake of respectively 2.2±1.1 g/day vs. 2.5±1.2 g/day (P=0.3621). The SBP was measured by the investigators at D0 and D56. It significantly (P<0.0001) decreased more in the Symbiosal group from 133.8±5.7 mmHg to 126.1±6.5 mmHg which correspond to a reduction of 7.7±5.9 mmHg while it slightly increased in the group NaCl from 136.6±10.3 mmHg to 140.4±8.3 mmHg which corresponds to an increase of 3.7±6 mmHg (main criteria). The proportion of subjects whose SBP was under 130 mmHg strongly and significantly more important in the Symbiosal group =77.3% vs. 10.5% in the NaCl group (P<0.0001).
This controlled randomized double-blind trial comparing Symbiosal to standard salt in the framework of a salt reduction demonstrate the efficiency of Symbiosal to prevent hypertension by controlling the BP rising in subject presenting prehypertensive status which is the target population of that food supplement.
由于与先前认为正常的血压水平相关的心血管并发症风险显著增加，美国国家高血压教育计划（JNC）第7次报告引入了一种新的分类，将收缩压在120 - 139 mmHg和/或舒张压在80 - 89 mmHg的人群称为“高血压前期”。在卫生当局建议减少盐摄入的框架下，本试验评估使用Symbiosal®是否比标准食用海盐（氯化钠）更能降低高血压前期的发生率。
研究设计：单中心、随机、双盲、对照试验，比较根据特定专利的Symbiosal（含3%壳聚糖的海盐氯化钠）和标准食用海盐氯化钠。研究采用2个平行组设计：每个受试者根据随机分组接受Symbiosal或氯化钠。
本临床试验的主要目的是证明，在高血压前期患者将食盐摄入量降至每天最多3克的框架下，Symbiosal比氯化钠能更显著地降低收缩压（SBP）。结果：根据随机分组，Symbiosal组纳入22名受试者，氯化钠组纳入19名受试者。两组的食盐摄入量相同：分别为每日2.2±1.1克/天和2.5±1.2克/天（P = 0.3621）。研究人员在第0天和第56天测量收缩压。Symbiosal组收缩压从133.8±5.7 mmHg显著（P<0.0001）下降至126.1±6.5 mmHg，降幅为7.7±5.9 mmHg，而氯化钠组收缩压从136.6±10.3 mmHg略有上升至140.4±8.3 mmHg，增幅为3.7±6 mmHg（主要标准）。收缩压低于130 mmHg的受试者比例在Symbiosal组显著更高，为77.3%，而在氯化钠组为10.5%（P<0.0001）。
在减少盐摄入的框架下，将Symbiosal与标准盐进行比较的这项对照随机双盲试验表明，Symbiosal通过控制处于高血压前期状态受试者的血压升高来预防高血压是有效的，而这些受试者正是该食品补充剂的目标人群。
