TY - JOUR
T1 - Appethyl® and reduction of body weight
T2 - evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
AU - Knutsen, Helle Katrine
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J.
AU - Naska, Androniki
AU - Pentieva, Kristina
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Bresson, Jean Louis
AU - Fiolet, Thibault
AU - Siani, Alfonso
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - Publisher Copyright:
© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2023/10/11
Y1 - 2023/10/11
N2 - 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.
AB - 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.
KW - energy restriction
KW - health claims
KW - spinach leaves aqueous extract
KW - thylakoids
KW - weight reduction
UR - http://www.scopus.com/inward/record.url?scp=85174582094&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/37829005
U2 - 10.2903/j.efsa.2023.8239
DO - 10.2903/j.efsa.2023.8239
M3 - Article
C2 - 37829005
AN - SCOPUS:85174582094
SN - 1831-4732
VL - 21
JO - EFSA Journal
JF - EFSA Journal
IS - 10
M1 - e08239
ER -