EFSA health claims

Table salt replacer not proven to lower blood pressure

By Shane STARLING contact

- Last updated on GMT

Related tags: Blood pressure

NDA finds one intervention trial with positive results not enough
NDA finds one intervention trial with positive results not enough
EFSA has rejected a German health claim submission that a table salt replacer could significantly lower blood pressure even though a clinical trial showed significant results.

The European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) found data lacking to back German firm Han-Asiabiotech’s submission that its patented 97% salt, 3% chitosan Symbiosal salt replacer could lower blood pressure and reduce the risk of hypertension.

Chitosan is a glucosamine-imbued polysaccharide that has an approved, general function, article 13.1 blood cholesterol management claim for 3 g/day under the EU nutrition and health claims regulation (NHCR) but the NDA said evidence was lacking in this article 14 disease risk factor reduction claim.

Positive effects, negative opinion

The dossier fulcrum was a 40-person, gold standard intervention study where participants had stage 1 hypertension and received Symbiosal at 3 g/day or table salt added into their diets.

“Results of a paired t‑test on the intention-to-treat population indicated that the reductions of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were higher when Symbiosal was consumed instead of table salt,”​ the NDA said.

“Similar results were obtained in a “per protocol” analysis. Highly significant period effects were observed for SBP and DBP, i.e. most of the reductions in blood pressure were observed during the first cross-over period. The Panel notes that significant period effects were observed for SBP and DBP. The Panel also notes that blood pressure did not return to baseline after the washout period.”

“The Panel considers that this study with methodological limitations showed a decrease in SBP and DBP when 3 g Symbiosal per day was consumed instead of table salt as added salt for eight weeks accompanied by a salt-restricted diet.”

Despite that positive finding for the 8-week study the NDA said the paired t‑test method was limited when carry-over periods were involved and said that the results were not replicated in animal studies.

It also said data was lacking to back a mechanism of action for the effect.

The Panel considers that the animal studies did not support the human study and that no evidence was provided for a mechanism by which Symbiosal could lower blood pressure when consumed instead of table salt.

It therefore concluded a cause and effect relationship was not established.

The NDA opinion is here.

Han-Asiabiotech submitted the claim that Symbiosal “lowers the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for hypertension.”​  

The targeted population was “healthy mild hypertensive subjects, and people who want/need to lower the rising of their blood pressure”.

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