Scientific Opinion on the substantiation of a health claim related to Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
EFSA Journal 2013;11(2):3087 [12 pp.].
doi
10.2903/j.efsa.2013.3087
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Panel Members
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Acknowledgement

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Sean (J.J.) Strain, Inge Tetens, Dominique Turck, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
the Competent Authority of Spain following an application by S.A. Vichy Catalan
Question Number
EFSA-Q-2012-00872
Adopted
24 January 2013
Published
12 February 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (190.95 KB)190.95 KB
Abstract

Following an application from S.A. Vichy Catalan, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response. The food, Vichy Catalan carbonated natural mineral water, that is the subject of the health claim is sufficiently characterised. The claimed effect, reduction of post-prandial lipaemic response, is a beneficial physiological effect. In weighing the evidence, the Panel took into account that the results of the only study from which conclusions could be drawn for the scientific substantiation of the claim do not support an effect of Vichy Catalan carbonated natural mineral water on the reduction of post-prandial lipaemic response. A cause and effect relationship has not been established between the consumption of Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response.

Summary

Following an application from S.A. Vichy Catalan submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application included a request for the protection of proprietary data.

The food that is the subject of the health claim is Vichy Catalan carbonated natural mineral water. The Panel considers that Vichy Catalan carbonated natural mineral water is sufficiently characterised.

The claimed effect is “reduction of post-prandial triglyceride concentrations”. The target population proposed by the applicant is “the healthy adult population”. The Panel considers that reduction of post-prandial lipaemic response is a beneficial physiological effect.

The applicant identified through a literature search five human intervention studies reported in six publications and one letter to the editor as being pertinent to the claim.

Two of these human intervention studies assessed the effect of Vichy Catalan carbonated natural mineral water on post-prandial lipaemic response.

An open-label, randomised, three-way cross-over study in 18 post-menopausal women investigated the effect of consuming Vichy Catalan carbonated natural mineral water, Vichy Catalan carbonated natural mineral water high in fluoride (7.9 mg/L), and a non-carbonated mineral water low in minerals (control) on post-prandial triglyceride concentrations. Mineral water (0.5 L) was consumed with a standard meal after an overnight fast and a standardised dinner. Endpoints investigated in the study were post-prandial serum and chylomicron triglyceride and cholesterol concentrations. The primary endpoint of the study was not specified. Post-hoc power calculations performed by the applicant showed that the study had 70 % power to detect differences in post-prandial triglyceride concentrations calculated as total area under the curve (tAUC) between groups. Statistically significant main effects of treatment were observed for both serum and chylomicron triglyceride concentrations (p=0.028 and p=0.049, respectively) using two factor repeated-measures analysis of variance with treatment and time as factors. No statistically significant treatment x time interactions were reported for any of these variables. Pair-wise comparisons showed significant differences in post-prandial serum triglyceride concentrations between the Vichy Catalan carbonated natural mineral water and control (p=0.05). Pair-wise comparisons performed with respect to chylomicron triglycerides did not reach statistical significance. Similar results were obtained from the analysis using the tAUC, which showed a significant decrease in the tAUC of serum triglycerides after consumption of Vichy Catalan carbonated natural mineral water vs. control (p<0.05). No statistically significant differences in the tAUC for chylomicron triglycerides, or in peak concentrations of serum and chylomicron triglycerides, were observed between individual mineral waters.

The Panel notes the small sample size of the study, that the primary outcome of the study was not specified, and that the level of significance used in the statistical analysis was not adjusted to take into account the multiple endpoints assessed in the study. The Panel considers that this study does not support an effect of Vichy Catalan carbonated natural mineral water on post-prandial lipaemic response.
In the open-label, randomised, four-way cross-over study, which was provided by the applicant as supportive evidence, the effect of consumption of Vichy Catalan carbonated natural mineral water vs. a non-carbonated mineral water low in minerals, with and without a standard meal, on post-prandial blood concentrations of triglycerides was investigated in 21 subjects. The Panel notes that blood triglyceride concentrations were still rising at the time blood sampling was terminated at 120 min and that the duration of blood sampling was insufficient to allow an assessment of the post-prandial blood triglyceride curve. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.

The Panel notes that in the absence of evidence for an effect of Vichy Catalan carbonated natural mineral water on post-prandial lipaemia in humans, studies on potential mechanisms do not provide evidence for the scientific substantiation of the claim.

In weighing the evidence, the Panel took into account that the results of the only study from which conclusions could be drawn for the scientific substantiation of the claim do not support an effect of Vichy Catalan carbonated natural mineral water on the reduction of post-prandial lipaemic response.

The Panel concludes that a cause and effect relationship has not been established between the consumption of Vichy Catalan carbonated natural mineral water and reduction of post-prandial lipaemic response.

Keywords
Vichy Catalan, mineral water, triglycerides, lipaemic response, health claims
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Number of Pages
12