ID 3145 - Spirulina

PL: Spirulina
EN: Spirulina
Pdf:

Oświadczenie (2)

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effects are “contributes/help maintain a healthy blood sugar level”, “glucose metabolism”, “glycaemic health”, “sugar metabolism”, and “digestion and metabolism of carbohydrates”. 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 long- term maintenance or achievement of normal blood glucose concentrations.
The Panel considers that long-term maintenance of normal blood glucose concentrations is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stężenia glukozy we krwi

Most of the references provided addressed food(s)/food constituent(s) other than those for which the specific claims are proposed and/or claimed effects other than blood glucose concentrations. This includes general reviews on the “anti-diabetic” properties of food(s)/food constituent(s) traditionally used in certain countries in the management of diabetic patients. The Panel considers that no scientific conclusions can be drawn from these references for the substantiation of the claim.
No studies in humans investigating the effects of the food(s)/food constituent(s) on blood glucose concentrations in healthy subjects, in subjects with impaired glucose tolerance or in diabetic subjects not on anti-diabetic medications have been provided in relation to any of the health claims evaluated in this opinion.
Some human intervention studies investigating the effects of the food(s)/food constituent(s) on blood glucose concentrations including subjects with diagnosis of type 2 diabetes under conventional oral anti-diabetic medications and/or insulin therapy were provided. The Panel considers that the evidence provided in these studies does not predict the occurrence of an effect of the food(s)/food constituent(s) on maintenance or achievement of normal blood glucose concentrations in the general population. Thus, for claims supported only by references to human studies on diabetic subjects under anti-diabetic treatment, the Panel considers that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effect in the general population.
A number of in vitro studies were provided addressing the capacity of different food(s)/food constituent(s) in inhibiting certain enzymes involved in carbohydrate metabolism (e.g. α-amylase, α-glucosidase). Also, studies were provided on the relationship between the consumption of the food(s)/food constituent(s) and the claimed effect by measuring blood glucose and/or insulin concentrations in animals (usually animal models of experimentally-induced diabetes, or genetically
prone to hyperglycaemic conditions). The Panel considers that the evidence provided in the animal and in vitro studies submitted is not sufficient to predict the occurrence of an effect of the food(s)/food constituent(s) on maintenance or achievement of normal blood glucose concentrations in vivo in humans. The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a health claim. Thus, for claims supported by references to animal studies and/or in vitro studies only, the Panel considers that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and long-term maintenance of normal blood glucose concentrations.

Warunki i możliwe ograniczenia stosowania oświadczenia

1 500 mg/d for 2 months