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

EFSA Journal 2010; 8(5):1603 [9 pp.]. doi:10.2903/j.efsa.2010.1603
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen Acknowledgment The Panel wishes to thank Joanne A. Harrold and the members of the Working Group on Claims for the preparatory work on this opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Gencor Pacific Inc. Question number: EFSA-Q-2010-00028 Adopted: 30 April 2010 Published: 12 May 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
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 body fat”. Slimaluma® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. The reduction in body weight is considered a beneficial physiological effect. A double blind, placebo controlled, randomised trial in humans investigating the effects of Slimaluma® on body fat was considered as being pertinent to the claim. No statistically significant differences in body fat changes between the experimental and placebo groups were reported. 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 body fat.

© European Food Safety Authority, 2010

Summary

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 body fat”.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The food constituent that is the subject of the health claim is an ethanol-water extract of Caralluma fimbriata (Slimaluma®). The ethanol-water extract of the aerial parts of Caralluma fimbriata is the source of the ingredients in Slimaluma® claimed as “active” by the applicant. The specific extraction and subsequent manufacturing processes are specified for the content of pregnane glycosides (at least 25 % by weight), which are claimed by the applicant to be the active ingredients for appetite control, of saponin glycosides (at least 10 % by weight) and of bitters (at least 3 % by weight). The Panel considers that the food constituent, ethanol-water extract of Caralluma fimbriata (Slimaluma®), which is the subject of the health claim, is sufficiently characterised.

The claimed effect is “helps to reduce body fat”. The target population is overweight adults (i.e., > 18 years of age). The Panel considers that a reduction in body fat mass might be a beneficial physiological effect.

Ten publications were identified by the applicant as being pertinent to the claim. The references provided included in vitro studies, intervention studies and reviews on the reliability and validity of Visual Analogue Scales for the assessment of appetite, the central control of body weight and appetite, the link between leptin and obesity, the impact of soluble fibres or multivitamin and mineral supplements on body weight and mitotic clonal expansion. The Panel considers that no scientific conclusions can be drawn from these references for the substantiation of the claimed effect.

Among the publications submitted, two published human intervention studies, an unpublished animal study and an unpublished in vitro study investigated the effects of ethanol-water extract of Caralluma fimbriata. Only one of the human intervention studies reported on measures of body fat and as such was considered pertinent to the claim.

The human study was a double blind, placebo controlled, randomised intervention in 62 healthy overweight and obese volunteers. The experimental group received 1 g of ethanol-water extract of Caralluma fimbriata per day for 60 days whilst the placebo group received maltodextrin capsules. At day 60, significant reductions in body fat were only observed in the experimental group compared to baseline. No significant changes in the estimated percentage of body fat were observed between the two groups over the duration of the study.

The Panel considers that the results from the animal study and the one in vitro study do not predict an effect of the ethanol-water extract of Caralluma fimbriata in Slimaluma® on the reduction of body fat in humans.

In weighing the evidence, the Panel took into account that in the one human study assessing changes in body fat no significant effect of the ethanol-water extract of Caralluma fimbriata on body fat mass 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 ethanol-water extract of Caralluma fimbriata Slimaluma® and the reduction in body fat.

Keywords

Slimaluma®, Caralluma fimbriata, pregnane glycosides, body fat, health claims.