Effect of NaCl + Chitosan 3% vs. NaCl on high blood pressure parameters of healthy volunteers with prehypertension.

Background: 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).

Methods: 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.

Study Objectives: 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).

Conclusions: 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.