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Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Following an application from Greenleaf Medical 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 Nutrition, Novel Foods and Food allergens (NDA) was asked to deliver an opinion on the...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10565634/ https://www.ncbi.nlm.nih.gov/pubmed/37829005 http://dx.doi.org/10.2903/j.efsa.2023.8239 |
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author | Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Fiolet, Thibault Siani, Alfonso |
author_facet | Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Fiolet, Thibault Siani, Alfonso |
collection | PubMed |
description | Following an application from Greenleaf Medical 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 Nutrition, Novel Foods and Food allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Appethyl® and reduction of body weight. Appethyl® is an aqueous extract from spinach leaves standardised by the manufacturing process and its lipase/colipase inhibition capacity in vitro. The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight/obese individuals. The applicant identified a total of three human intervention studies that investigated the effects of Appethyl® on body weight as being pertinent to the claim. In weighing the evidence, the Panel took into account that Appethyl® (5 g/day for 12 weeks) had no effect on body weight as compared to placebo under minimal dietary counselling and moderate physical activity, and that no beneficial physiological effects are to be expected for the target population of overweight/obese individuals from the weight loss that could be attributed to the intervention with Appethyl® under predefined energy restriction and moderate physical activity. The Panel also considered that the effect of Appethyl® (5 g/day for 24 weeks) on body weight maintenance after initial weight loss shown in one study has not been replicated in different settings, which questions the external validity of the results, and that no evidence was provided for a plausible mechanism by which daily consumption of Appethyl® could exert a sustained effect on body weight in humans. The Panel concludes that a cause‐and‐effect relationship has not been established between the consumption of Appethyl® and a reduction of body weight under the conditions of use proposed by the applicant. |
format | Online Article Text |
id | pubmed-10565634 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-105656342023-10-12 Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Fiolet, Thibault Siani, Alfonso EFSA J Scientific Opinion Following an application from Greenleaf Medical 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 Nutrition, Novel Foods and Food allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Appethyl® and reduction of body weight. Appethyl® is an aqueous extract from spinach leaves standardised by the manufacturing process and its lipase/colipase inhibition capacity in vitro. The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight/obese individuals. The applicant identified a total of three human intervention studies that investigated the effects of Appethyl® on body weight as being pertinent to the claim. In weighing the evidence, the Panel took into account that Appethyl® (5 g/day for 12 weeks) had no effect on body weight as compared to placebo under minimal dietary counselling and moderate physical activity, and that no beneficial physiological effects are to be expected for the target population of overweight/obese individuals from the weight loss that could be attributed to the intervention with Appethyl® under predefined energy restriction and moderate physical activity. The Panel also considered that the effect of Appethyl® (5 g/day for 24 weeks) on body weight maintenance after initial weight loss shown in one study has not been replicated in different settings, which questions the external validity of the results, and that no evidence was provided for a plausible mechanism by which daily consumption of Appethyl® could exert a sustained effect on body weight in humans. The Panel concludes that a cause‐and‐effect relationship has not been established between the consumption of Appethyl® and a reduction of body weight under the conditions of use proposed by the applicant. John Wiley and Sons Inc. 2023-10-11 /pmc/articles/PMC10565634/ /pubmed/37829005 http://dx.doi.org/10.2903/j.efsa.2023.8239 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Knutsen, Helle Katrine Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pentieva, Kristina Thies, Frank Tsabouri, Sophia Vinceti, Marco Bresson, Jean‐Louis Fiolet, Thibault Siani, Alfonso Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
title | Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
title_full | Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
title_fullStr | Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
title_full_unstemmed | Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
title_short | Appethyl® and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 |
title_sort | appethyl® and reduction of body weight: evaluation of a health claim pursuant to article 13(5) of regulation (ec) no 1924/2006 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10565634/ https://www.ncbi.nlm.nih.gov/pubmed/37829005 http://dx.doi.org/10.2903/j.efsa.2023.8239 |
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