Following an application from Gencor Pacific Inc. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and “helps to reduce waist circumference”. Slimaluma® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. The Panel considers that a reduction in waist circumference, if accompanied by improvement in adverse health effects of an excess abdominal fat, is a beneficial physiological effect. One human intervention provided reported a statistically significant effect of ethanol-water extract of Caralluma fimbriata on the reduction of waist circumference in humans compared to a suitable control. No significant differences in body weight, body fat, blood glucose or lipid profiles were observed over time between the two groups. In weighing the evidence, the Panel took into account that whilst waist circumference was significantly reduced in the experimental group compared to placebo after 60 days of intervention in one of the human studies presented assessing this outcome, no significant effect of the ethanol-water extract of Caralluma fimbriata on waist circumference leading to an improvement in adverse health effects associated with an excess abdominal fat was observed when compared to a suitable control. The Panel concludes that a cause and effect relationship has not been established between the consumption of the ethanol-water extract of Caralluma fimbriata Slimaluma® and a reduction in waist circumference leading to an improvement in adverse health effects associated with an excess abdominal fat

Scientific Opinion on the substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and helps to reduce waist circumference pursuant to Article 13(5) of Regulation (EC) No 1924/2006 / C.V. Agostoni, J.L. Bresson, S. Fairweather Tait, A. Flynn, I. Golly, H. Korhonen, P. Lagiou, M. Løvik, R. Marchelli, A. Martin, B. Moseley, M. Neuhäuser Berthold, H. Przyrembel, S. Salminen, Y. Sanz, S. Strain, S. Strobel, I. Tetens, D. Tomé, H. van Loveren, H. Verhagen. - In: EFSA JOURNAL. - ISSN 1831-4732. - 8:5(2010). [10.2903/j.efsa.2010.1602]

Scientific Opinion on the substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and helps to reduce waist circumference pursuant to Article 13(5) of Regulation (EC) No 1924/2006

C.V. Agostoni
Primo
;
2010

Abstract

Following an application from Gencor Pacific Inc. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and “helps to reduce waist circumference”. Slimaluma® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. The Panel considers that a reduction in waist circumference, if accompanied by improvement in adverse health effects of an excess abdominal fat, is a beneficial physiological effect. One human intervention provided reported a statistically significant effect of ethanol-water extract of Caralluma fimbriata on the reduction of waist circumference in humans compared to a suitable control. No significant differences in body weight, body fat, blood glucose or lipid profiles were observed over time between the two groups. In weighing the evidence, the Panel took into account that whilst waist circumference was significantly reduced in the experimental group compared to placebo after 60 days of intervention in one of the human studies presented assessing this outcome, no significant effect of the ethanol-water extract of Caralluma fimbriata on waist circumference leading to an improvement in adverse health effects associated with an excess abdominal fat was observed when compared to a suitable control. The Panel concludes that a cause and effect relationship has not been established between the consumption of the ethanol-water extract of Caralluma fimbriata Slimaluma® and a reduction in waist circumference leading to an improvement in adverse health effects associated with an excess abdominal fat
Slimaluma® ; Caralluma fimbriata ; pregnane glycosides ; waist circumference ; health claims
Settore MED/49 - Scienze Tecniche Dietetiche Applicate
2010
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/156443
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