ID 3162 - Kwas liponowy

PL: Kwas liponowy
EN: Alpha Lipoic acid (ALA)
Pdf: alpha-lipoic acid

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is alpha-lipoic acid.
Alpha-lipoic acid, also known as thioctic acid, is a non-essential sulphur-containing food constituent structurally well-defined and present in foods generally bound to protein (lipoyllysine) at very low concentrations (around 0.3 mg/100 g for the richest natural sources, i.e., spinach for vegetables and kidney for meat). The natural compound is the R enantiomer, while in food supplements generally the racemic form (R/S) is used. It exists in redox forms, the oxidised form with a closed cycle containing a disulfide bond or a reduced form, with an open ring containing two thiol groups (dihydrolipoic acid). Alpha-lipoic acid is measurable in foods by established methods.
The Panel considers that the food constituent, alpha-lipoic acid, which is the subject of the health claims is sufficiently characterised.

2.4. Utrzymanie prawidłowego stężenia glukozy we krwi (ID 1435, 3162)

The claimed effects are “metabolism of carbohydrates” and “metabolism of glucose”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers 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

The major metabolic role of alpha-lipoic acid is to act as a coenzyme in important metabolic pathways, especially decarboxylation of α-ketoacids, in which it functions in association with thiamine and nicotinamide containing enzymes.
Thirty seven references have been provided to support the claimed effects, consisting of 14 narrative reviews, 5 human studies, 11 animal studies in rat or mouse models of diabetes and two in vitro studies. References unrelated to the food constituent, to the claimed effects, or using parenteral routes of administration of the food constituent or performed in patients not representative of the target population (e.g., diabetic patients with poor glycaemic control and albuminuria) were not considered pertinent for the substantiation of the claimed effects.

3.4. Utrzymanie prawidłowego stężenia glukozy we krwi (ID 1435, 3162)

All the references provided reporting on human intervention studies with alpha-lipoic acid relate to the treatment of type 2 diabetes and its complications (e.g., insulin resistance, impaired glucose tolerance, chronic hyperglycaemia, protein glycation, peripheral and/or autonomic neuropathy). The Panel considers that results obtained in this pharmacologically treated population subgroup cannot be extrapolated to the general population.
A number of studies on the prevention of type 2 diabetes and its complications in animal models have been presented. Also, some in vitro studies investigating the mechanism by which alpha-lipoic acid might modulate glucose metabolism in type 2 diabetes have been cited. The Panel considers that the results obtained in these studies do not predict an effect of alpha-lipoic acid on the maintenance of normal blood glucose concentrations in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and long-term maintenance of normal blood glucose concentrations.

Warunki i możliwe ograniczenia stosowania oświadczenia

150-450 mg daily, not recommended for children under the age of 12, it should not be used during pregnancy and lactation, it should not to be used for patients with insufitiention of thiamin unless this insufitiontion is treated