Double blind, randomized, controlled clinical trial of NaCl + Chitosan 3% vs. NaCl on the decrease of blood pressure induced by a low salt diet in healthy prehypertensive volunteers

Because of the impressive increase in the risk of cardiovascular complications associated with levels of blood pressure (BP) previously considered as normal, the JNC 7 report has introduced a new classification that includes the term “prehypertension” for those with BP 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 evaluated if the use of Symbiosal® reduces more prehypertension than standard table marine salt (NaCl). Study design: monocentric, randomized, double blind, controlled trial comparing the marine salt NaCl + Chitosan 3% (specific patent Symbiosal) and the standard table marine salt NaCl. The study has been conducted in 2 parallel arms: 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. Twenty-two subjects were included in the Symbiosal group and 19 in the NaCl group after 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. SBP significantly decreased more in the Symbiosal group from 133.8 ± 5.7 mmHg to 126.1 ± 6.5 mmHg (P < 0.0001) corresponding 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 was 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 in subject presenting prehypertensive status which is the target population of that food supplement.