ID 3134 - 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.

2.1. Ochrona lipidów we krwi przed uszkodzeniem oksydacyjnym (ID 1434, 3134)

The claimed effects are “antioxidant properties” and “fat metabolism”. 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 relate to the protection of body lipids from oxidative damage caused by free radicals.
Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g., respiratory chain) and as a consequence of exposure to exogenous factors (e.g. radiation, pollutants). These reactive intermediates damage biologically relevant molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers like antioxidant nutrients.
The Panel considers that protection of body lipids from oxidative damage may be a beneficial physiological effect.

2.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 3134)

The claimed effect is “fat metabolism”. The Panel assumes the target population is the general population.
In the context of the proposed wording “might also help to keep normal level of blood cholesterol”, the Panel assumes that the claimed effect relates to the maintenance of normal blood cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL, may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

2.3. Zwiększenie beta-oksydacji kwasów tłuszczowych (ID 3134)

The claimed effect is “fat metabolism”. The Panel assumes the target population is overweight subjects in the general population who wish to reduce their fat mass.
In the context of the proposed wording “has positive effects on fat burning”, the Panel assumes that the claimed effect relates to an increased beta-oxidation of fatty acids leading to a reduction in body fat mass.
The Panel considers that an increased beta-oxidation of fatty acids leading to a reduction in body fat mass may be 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.

3.1. Ochrona lipidów we krwi przed uszkodzeniem oksydacyjnym (ID 1434, 3134)

One randomised controlled trial in humans, which was provided in the consolidated list, was considered pertinent for the substantiation of the claimed effect.
In the study by Marangon et al. (1999) a total of 31 healthy adults were supplemented for two months either with alpha-lipoic acid alone (600 mg/d, n =16), with alpha-tocopherol alone (400 IU/d, n=15), and then with the combination of both for two additional months. At baseline, and after two and four months of supplementation, urine F2-isoprostanes, low-density lipoprotein (LDL) susceptibility to oxidation and plasma protein carbonyls was assessed. The Panel notes the absence of an appropriate control group and the lack of a direct statistical comparison between the alpha-lipoic acid and the alpha-tocopherol interventions, which greatly limit the conclusions that can be drawn from this study for the substantiation of the claimed effect.
From the narrative reviews provided with the consolidated list, alpha-lipoic acid is a well recognised antioxidant due to its low redox potential: it scavenges hydroxyl radicals, hypochlorous acid, and singlet oxygen. It does not scavenge hydrogen peroxide or superoxide radical and probably does not scavenge peroxyl radicals; it may chelate transition metals involved in oxidation reactions; it also appears to increase intracellular glutathione. In addition, dihydrolipoic acid, readily formed in the body from alpha-lipoic acid, appears to be able to regenerate other antioxidants, such as ascorbate and (indirectly) vitamin E, from their radical forms. However, most of the data comes from in vitro studies and animal models of diabetes, which do not predict the occurrence of an effect by the consumption of alpha-lipoic acid on the protection of body lipids from oxidative damage in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and the protection of body lipids from oxidative damage.

3.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 3134)

No specific reference has been provided in relation to this claimed effect. Reduction of blood cholesterol concentrations is not a property attributed to alpha-lipoic acid in the reviews provided. In addition, in the study by Marangon et al. (1999) conducted in healthy subjects, total, LDL- and HDL- cholesterol concentrations were not significantly affected by two-month alpha-lipoic acid supplementation at doses of 600 mg/d.
The Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and the maintenance of normal blood cholesterol concentrations.

3.3. Zwiększenie beta-oksydacji kwasów tłuszczowych (ID 3134)

Though the biochemical role of alpha-lipoic acid in the function of certain enzymes involved in the Krebs cycle (which metabolises acetyl-CoA resulting from the catabolism of fatty acids) is well established, no study has been provided on the effect of consumption of alpha-lipoic acid on the promotion of beta-oxidation of fatty acids, neither on the effects of consumption of alpha-lipoic acid on body fat mass.
The Panel concludes that a cause and effect relationship has not been established between the consumption of alpha-lipoic acid and an increased beta-oxidation of fatty acids leading to a reduction in body fat mass.

Warunki i możliwe ograniczenia stosowania oświadczenia

150 - 450 mg daily