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Among the publications submitted, two published human intervention studies, an unpublished animal study and an unpublished in vitro study investigated the effects of ethanol-water extract of Caralluma fimbriata.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.