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

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Article
EFSA Journal 2010; 8(5):1604 [11 pp.].
doi
10.2903/j.efsa.2010.1604
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.
Acknowledgement

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
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
Gencor Pacific Inc.
Question Number
EFSA-Q-2010-00029
Adopted
30 April 2010
Published
12 May 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (189.65 KB)189.65 KB
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 weight”. 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. Two human intervention studies were considered as being pertinent to the claim. Neither of the studies provided reported a significant effect of ethanol-water extract of Caralluma fimbriata on weight loss in humans 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 body weight.

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 weight”.

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 weight”. The target population is overweight adults (i.e., > 18 years of age). The Panel considers that a reduction in body weight is 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.

The first 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. There were no significant differences reported for changes in body weight between the two groups at any time point.

The second human study was a placebo controlled randomised intervention in 26 overweight volunteers. The experimental group received one 500 mg capsule of ethanol-water extract of Caralluma fimbriata 30 minutes before each meal for four weeks. The nature of the placebo was not specified. Whilst the study reports a statistically significant weight loss in the intervention group, there is no indication as to whether this difference lies between the experimental and placebo group or between different time points for the experimental group. The Panel notes that mean body weight changes in the intervention and control groups as well as details on the statistical analysis used are not reported. The Panel did not receive any further clarification from the applicant on this point. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.

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 Slimaluma® on the reduction of body weight in humans.

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

Keywords
Slimaluma®, Caralluma fimbriata, pregnane glycosides, body weight, health claims
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Number of Pages
11