Scientific Opinion on the substantiation of a health claim related to a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2014;12(7):3752 [8 pp.].
doi
10.2903/j.efsa.2014.3752
Panel members at the time of adoption
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.
Acknowledgements

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, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, 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
Competent Authority of Sweden following an application by DoubleGood AB
Question Number
EFSA-Q-2013-00756
Adopted
25 June 2014
Published
14 July 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from DoubleGood AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic responses. The Panel considers that the food is sufficiently characterised. The target population proposed by the applicant is “adults in the general population wishing to reduce their post-prandial blood glucose responses”. The mechanism proposed by the applicant for the claimed effect is “stimulating insulin release via the insulinogenic properties of the amino acids in the food”. The Panel notes that the evidence provided by the applicant does not establish that a reduction in post-prandial glycaemic responses achieved by an increase in insulin secretion is a beneficial physiological effect for the target population in the context of this application. The Panel considers that a cause and effect relationship has not been established between the consumption of the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, and a beneficial physiological effect for the target population.

Summary

Following an application from DoubleGood AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic responses.

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 a combination of five amino acids, i.e. L-threonine, L-valine, L-leucine, L-isoleucine and L-lysine, plus chromium picolinate, which are dissolved in table water. The amounts of the single constituents, an overview of the manufacturing process and information on stability and batch-to-batch analyses were provided. The Panel considers that the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, is sufficiently characterised.

The claimed effect is “reduces the post-prandial blood glucose response”. The target population proposed by the applicant is “adults in the general population wishing to reduce their post-prandial blood glucose responses”.

Decreasing post-prandial glycaemic responses may be beneficial, for example, to individuals with impaired glucose tolerance, as long as post-prandial insulinaemic responses are not disproportionally increased. In view of the proposed mechanism, i.e. “stimulating insulin release via the insulinogenic properties of the amino acids in the food”, the applicant was invited to provide evidence that a reduction of post-prandial blood glucose responses achieved by an increase in insulin secretion is a beneficial physiological effect for the proposed target population. No such evidence was provided by the applicant.

The Panel notes that the evidence provided by the applicant does not establish that a reduction in post-prandial glycaemic responses achieved by an increase in insulin secretion is a beneficial physiological effect for the target population in the context of this application.

The Panel considers that a cause and effect relationship has not been established between the consumption of the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, which is the subject of the health claim, and a beneficial physiological effect for the target population.

Keywords
amino acids, chromium picolinate, post-prandial glycaemic responses, health claims
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Number of Pages
8