Following an application from Kemin Foods LC, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Slendesta® Potato Extract and reduction of body weight.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application included a request for the protection of proprietary data.
The food constituent that is the subject of the health claim is Slendesta® Potato Extract. The Panel considers that Slendesta® Potato Extract is sufficiently characterised.
The claimed effect proposed by the applicant is reduction of body weight. The target population proposed by the applicant is “overweight adults wishing to lose weight”. The Panel considers that a reduction of body weight is a beneficial physiological effect for overweight individuals.
The applicant provided six reports on four randomised controlled trials (RCTs), two reports on one open label, single-arm study, and one meta-analysis of four of these studies.
The human intervention studies provided lasted between 6 and 20 weeks and examined the effect on body weight of 30 mg and/or 15 mg of proteinase inhibitor 2 (PI2) from Slendesta® Potato Extract to be consumed in two capsules, each taken 30-60 minutes prior to the two major meals.
One of these studies was an open label, single-arm intervention (no control group). The Panel notes that this study was uncontrolled, and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The remaining four human intervention studies provided used Satise® Satiety Aid (a food supplement containing Slendesta® Potato Extract as the only active ingredient) as a source of PI2, and magnesium stearate and microcrystalline cellulose as placebo. The number of subjects per group ranged from 20 to 81. Three of these studies were conducted as three-arm studies using doses of 0, 15 and 30 mg of PI2 per day, while one study used a 2x2 factorial design with 15 mg PI2 per day and dietary and lifestyle counselling as variables. In all but one study, in which daily calorie intake was restricted to 1,500 kcal per day, subjects consumed ad libitum diets. There was no effect of Slendesta® Potato Extract on reduction of body weight in any of these studies.
The applicant also presented a meta-analysis of four of the five studies presented. The study in which Slendesta® was consumed in the context of an energy restricted diet was not included in this meta-analysis. Upon request from EFSA to clarify why this study was excluded from the analysis, the applicant indicated that the purpose of the meta-analysis was to evaluate the effect of Slendesta® Potato Extract “without changes in lifestyle”. The Panel notes that the purpose of the meta-analysis as claimed by the applicant does not address the conditions of use proposed for the claim (i.e. the dietary and lifestyle conditions in which Slendesta® should be consumed in order to achieve the claimed effect are not specified). The Panel also notes that a study in which Slendesta® was administered together with dietary and lifestyle counselling was included in the meta-analysis, and therefore considers that the study selection is not appropriate to fulfil the purpose of this meta-analysis as claimed by the applicant. The Panel considers that no conclusions can be drawn from this meta-analysis for the scientific substantiation of the claim.
The Panel also notes that in the absence of evidence for an effect of Slendesta® Potato Extract on the reduction of body weight, the data provided by the applicant with respect to potential mechanisms by which Slendesta® Potato Extract could exert the claimed effect do not provide evidence for the scientific substantiation of the claim.
In weighing the evidence, the Panel took into account that all four human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of Slendesta® Potato Extract on the reduction of body weight.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Slendesta® Potato Extract and reduction of body weight.