EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found Estonian firm Piimandusühistu E-Piim’s dossier that contained 38 publications did not substantiate the proposed claim that read:
“Regular consumption (at least 3 weeks) of 50 g/day Südamejuust (Heart cheese) of Harmony brand comprising probiotic Lactobacillus plantarum TENSIA helps to maintain the cardio-vascular system/heart health through reduction of blood pressure.”
The NDA said of four submitted, proprietary, unpublished intervention studies investigating the effects of the strain L. plantarum (Tensia) on blood pressure, three were uncontrolled and therefore not permissible as evidence.
The fourth was controlled – a randomised, double-blind, placebo-controlled, cross-over human intervention study – but the NDA said, “no significant differences in systolic or diastolic blood pressure changes were observed between the intervention and control groups during the study.”
It added: “Post-hoc analyses were carried out by dividing the study population according to systolic blood pressure values at baseline. The Panel notes that these post-hoc analyses were not pre-planned and considers that no conclusions can be drawn from these analyses for the scientific substantiation of the claim.”
“In weighing the evidence, the Panel took into account that the only randomised, placebo-controlled human intervention study provided did not show an effect of consumption of L. plantarum TENSIAin Edam-type cheese on blood pressure.”
The 38 submitted publications includedguidelines, EFSA opinions, reports, narrative reviews, theses, human studies and ex vivo/in vitro mechanistic studies but the NDA said none of them, “addressed the effects of L. plantarum TENSIA”.
It also noted that in vitro informationabout the functional properties of L. plantarum TENSIA (available in two patents) to produce angiotensin-converting enzyme (ACE) inhibitors via, “proteolytic activity in the cheese environment during maturation” did not, “predict an effect of L. plantarum TENSIAon blood pressure in vivo in humans.”
The NDA opinion can be found here.