This scientific output, published on 18 May 2010, replaces the earlier version published on 12 May 2010.
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 waist circumference”.
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 waist circumference”. The target population is overweight adults (i.e., > 18 years of age). The Panel considers that the reduction in waist circumference, if accompanied by improvement in adverse health effects of an excess abdominal fat, is a beneficial physiological effect.
Thirteen 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 relationship between waist circumference and cardiovascular events, 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.
Among the publications submitted, two published human intervention studies reporting on measures of waist circumference, 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. At baseline and at the end of 30 and 60 days of intervention anthropometric measurements, including waist circumference, were obtained. Body weight, body fat, fasting blood glucose and lipid profiles (triglyceride, total and HDL cholesterol) were also measured at the same time points. A statistically significant reduction in waist circumference was observed in the intervention group compared to placebo at the end of study. No significant differences in body weight, body fat, blood glucose or lipid profiles were observed over time between the two groups. The Panel notes that the reduction in waist circumference observed in the intervention group compared to placebo was not associated to a reduction in body fat and did not lead to an improvement in adverse health effects associated with an excess abdominal fat (e.g., a reduction in blood glucose and/or an improvement in the lipid profile).
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. Thirteen subjects in the experimental group reduced their waist circumference compared to baseline. The impact of the intervention on the waist circumference of participants in the placebo group was not reported. It is also not reported whether the reductions in waist circumference observed in the experimental group reached statistical significance when compared to the placebo group. 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 a reduction of waist circumference in humans.
In weighing the evidence, the Panel took into account that whilst waist circumference was significantly reduced in the experimental group compared to placebo after 60 days of intervention in one of the human studies presented assessing this outcome, no significant effect of the ethanol-water extract of Caralluma fimbriata on waist circumference leading to an improvement in adverse health effects associated with an excess abdominal fat 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 waist circumference leading to an improvement in adverse health effects associated with an excess abdominal fat.