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 control hunger/appetite”.
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 control hunger/appetite”. The target population is overweight adults (i.e., > 18 years of age). The Panel considers that a reduction of appetite leading to a reduction in subsequent energy intake 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 conclusions can be drawn from these references for the substantiation of the claimed effect.
Only one of the human intervention studies reported on measures of appetite and as such was considered pertinent to the claim. It 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 baseline and at the end of 30 and 60 days of intervention assessment of appetite was performed in the fasted state using four visual analogue scales for ‘hunger’, ‘thoughts of food’, ‘urge to eat’ and ‘fullness of stomach’. At baseline and following 60 days of intervention, dietary intake was also assessed using a modified food frequency questionnaire. At day 60 only, the mean hunger level of the experimental group was found to be significantly lower than that of the placebo group. There were no significant differences reported for the other assessments of appetite over time within groups from baseline, or between the two groups. No differences in energy intake between the experimental and placebo groups were reported at day 60. The Panel notes that measurement of energy intake was via self-reported methods (rather than being measured directly within the laboratory), the validity of which is questionable.
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 appetite in humans.
In weighing the evidence, the Panel took into account that whilst the ratings of hunger were significantly reduced in the experimental group compared to placebo at day 60 in the one human study presented which assessed this outcome, no significant effect of the ethanol-water extract of Caralluma fimbriata on energy intake 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 of appetite leading to a reduction in subsequent energy intake.