ID 2925 - Alfa-cyklodekstryna

PL: Alfa-cyklodekstryna
EN: Alpha-cyclodextrin (a soluble dietary fiber)
Pdf: alpha-cyclodextrin

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food that is the subject of the health claims is alpha-cyclodextrin. Alpha-cyclodextrin (cyclohexaamylose or cyclomaltohexaose) is a cyclic saccharide comprised of six glucose units linked by alpha-1,4 bonds. It is produced by the action of cyclodextrin glucosyltransferase on hydrolysed starch syrups. The annular structure of alpha-cyclodextrin provides a hydrophobic cavity that allows
formation of inclusion complexes with a variety of non-polar organic molecules of appropriate size. The hydrophilic nature of the outer surface of the cyclic structure makes alpha-cyclodextrin water- soluble. Human salivary and pancreatic amylases cannot hydrolyse alpha-cyclodextrin to a significant extent, but alpha-cyclodextrin can be hydrolysed by alpha-amylases of bacterial origin in the human intestine. Alpha–cyclodextrin is considered a soluble dietary fibre.
The Panel considers that the food constituent, alpha-cyclodextrin, which is the subject of the health claims is sufficiently characterised.

2.2. Osiąganie lub utrzymywanie prawidłowej masy ciała (ID 2925)

The claimed effect is “weight management”. The Panel assumes that the target population is the general population.
Weight management can be interpreted as the contribution to the maintenance of a normal body weight. In this context even a moderate weight loss in overweight subjects without achieving a normal body weight is considered beneficial to health.
The Panel considers that the maintenance or achievement of a normal body weight is a beneficial physiological effect.

3.2. Osiąganie lub utrzymywanie prawidłowej masy ciała (ID 2925)

Among the four references provided, one full article and one abstract investigated the effects of alpha- cyclodextrin on health outcomes unrelated to the claimed effect (e.g., blood lipids, faecal excretion of saturated fat). The Panel considers that no conclusions can be drawn from this study for the substantiation of the claimed effect.
One human study and one animal study investigating the effects of alpha-cyclodextrin on body weight were submitted.
Grunberger et al. (2007) report the results from a randomised controlled trial in which 60 obese adults of both sexes on pharmacological treatment for type 2 diabetes were randomised to consume either placebo tablets (6 tablets/d, 1g tablet per fat-containing meal) or tablets containing alpha-cyclodextrin (6 tablets/d, 1g tablet per fat-containing meal) for 12 weeks. A total of 47 subjects completed the intervention and entered data analysis (controls n = 27). The placebo group gained on average 1.54 kg over 12 weeks, whereas the supplemented group gained 0.27 kg. This difference was only statistically significant after adjusting for energy intake, which was largest in the supplemented group.
Also a 6-week rat feeding study was presented investigating the effects of alpha-cyclodextrin added to low and high fat diets on body weight (Artiss et al., 2006). The Panel notes that the results of this study do not predict an effect of alpha-cyclodextrin intake on body weight in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-cyclodextrin and the maintenance or achievement of a normal body weight.

Warunki i możliwe ograniczenia stosowania oświadczenia

≥ 2 g/meal