ID 1656 -
Standaryzowany wyciąg z ziemniaków
PL: Standaryzowany wyciąg z ziemniaków
EN: Standardised Potato Extract
Pdf: various food(s)/food constituent(s) not supported by pertinent human data
1.2. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 1656, 1884, 2870, 2894, 4252)
The claimed effects are “satiety/weight management/promotion of CCK release and soy foods”, “alginate forms a gel in the stomach and promotes an immediate feeling of satiety. It may also trap a portion of HCA. Piperine increases the bioavailability of the un-trapped HCA and enhances satiety”, “satiety”, and “weight management/satiety”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to an increase in satiety. Satiety is the decrease in the motivation to eat after consumption of food. The effect may persist up to several hours, may reduce energy intake either at the next meal or across the day and, if sustained, may lead to a reduction in body weight.
The Panel considers that an increase in satiety leading to a reduction in energy intake, if sustained, might be a beneficial physiological effect.
1.3. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 559, 1380, 1656, 1806, 2243, 2325, 2331, 2333, 2336, 2717, 2727, 2788, 2870, 3726, 4252, 4709)
The claimed effects are “weight control; carbohydrate metabolism and insulin sensitivity”, “weight management”, “satiety/weight management/promotion of CCK release and soy foods”, “weight control”, “weight loss management, carbohydrate & lipid metabolism improvement”, “weight loss management, acid base balancer”, “weight management, thermogenesis”, “amincissement”, “slimming (cellulitis draining)”, and “weight management/satiety”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance or achievement of a normal body weight.
Weight management and weight control can be interpreted as contribution to the maintenance of a normal body weight. In this context, weight loss in overweight individuals without achieving a normal body weight is considered to be a beneficial physiological effect.
The Panel considers that contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.
2.2. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 1656, 1884, 2870, 2894, 4252)
The references provided in relation to these claims included narrative reviews on the regulation of appetite, energy intake and body weight which did not provide any original data for the scientific substantiation of the claims, addressed the effects of food(s)/food constituent(s) other than those which are the subject of the claims, and/or investigated health outcomes (e.g. post-prandial blood glucose and insulin responses, body composition) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
Some human intervention studies, which investigated the effect of the food(s)/food constituent(s) on appetite ratings and/or subsequent food intake and/or secretion of hormones with a putative role on the regulation of food intake (e.g. glucagon-like peptide-1, cholecystokinin, ghrelin) following a single meal or over 24 hours, were provided. The Panel notes that none of these studies tested the sustainability of an effect of the food(s)/food constituent(s) on appetite ratings and subsequent energy intake (i.e. effects were tested on a single occasion and no information was provided on the repeated consumption of the food(s)/food constituent(s)). The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of a claim on a sustained increase in satiety leading to a reduction in energy intake.
No human studies which investigated the effects of the food(s)/food constituent(s) on a sustained increase in satiety leading to a reduction in energy intake were provided in relation to any of the claims evaluated in this section.
A number of animal studies which addressed the effects of the food(s)/food constituent(s) on food intake, body weight, and/or secretion of hormones with a putative role on the regulation of food intake, and a number of animal and in vitro studies which addressed the mechanisms by which the food(s)/constituent(s) could exert the claimed effect were also provided. The Panel considers that, in the absence of human studies from which conclusions could be drawn for the scientific substantiation of the claim, the evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on an increase in satiety leading to a reduction in energy intake in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the claims evaluated in this section and a sustained increase in satiety leading to a reduction in energy intake.
2.3. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 559, 1380, 1656, 1806, 2243, 2325, 2331, 2333, 2336, 2717, 2727, 2788, 2870, 3726, 4252, 4709)
Most of the references provided in relation to these claims were narrative reviews on the potential health effects of different food(s)/food constituent(s) which did not provide any original data for the scientific substantiation of the claims, addressed the effects of food(s)/food constituent(s) other than those which are the subject of the claims, and/or investigated health outcomes (e.g. delayed gastric emptying, appetite ratings and/or subsequent food intake following a single meal or over 24 hours, energy expenditure, post-prandial blood glucose responses, insulin sensitivity and/or long-term blood glucose control, treatment of chronic venous insufficiency, bioavailability of different food constituents, on plasma concentrations of carotenoids, blood lipids and/or lipid metabolism, antioxidant properties and/or oxidative stress) other than body weight. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
For ID 2243 and 2325, summaries of two human intervention studies on the effects of the food constituents on body weight were provided. However, the limited methodological data available in the summaries did not allow a complete scientific evaluation. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
For ID 1656 and 2870, some internal reports identified as proprietary by the company reported on human intervention studies on the effects of the food constituents on body weight. The Panel notes that Regulation (EC) No 1924/2006 does not foresee the protection of proprietary data for health claims under Article 13.1 of the Regulation and therefore considers that these data cannot be used for the scientific substantiation of the claims.
No relevant human studies which investigated the effects of the food(s)/food constituent(s) on changes in body weight were provided in relation to any of the claims evaluated in this section.
A number of animal studies which addressed the effects of some of the food(s)/constituent(s) on body weight, and a number of animal and in vitro studies which addressed the mechanisms by which the food(s)/constituent(s) could exert the claimed effect were also provided. The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on body weight in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the claims evaluated in this section and contribution to the maintenance or achievement of a normal body weight.
Warunki i możliwe ograniczenia stosowania oświadczenia
Product-specific claim. 15-30 mg of proteinase inhibitors from the standardized potato extract ingredient, taken one hour before the meal, daily