ID 1432 -
Acetyl-L-Karnityna
PL: Acetyl-L-Karnityna
EN: Acetyl-l-carnitine
Pdf: acetyl-L-carnitine
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is acetyl-L-carnitine.
Acetyl-L-carnitine is an acetylated form of L-carnitine [(3,R)-hydroxy-4-N,N,N- trimethylaminobutanoate], a zwitterionic quaternary amino acid with a molecular weight of 161.5 Da of which only the L-isomer is biologically active. L-carnitine is derived from the essential amino acids L-lysine and L-methionine. Carnitine is generally abundant in food products of animal origin, whereas fruits, vegetables, grains and other plant-derived foods contain relatively small amounts of carnitine. Acetyl-L-carnitine can be formed inside mitochondria during exercise in conditions of high carnitine intake (by carnitine O-acetyltransferase). Acetyl-L-carnitine can be consumed in the form of food supplements.
The Panel considers that the food constituent, acetyl-L-carnitine, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effect is “neurological support”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to normal cognitive function. Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and which can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive function is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Udział w prawidłowym przebiegu procesów poznawczych
Among the references provided for the scientific substantiation of the claim were one textbook and six narrative reviews which did not provide any primary data that could be used for the scientific
substantiation of the claim, and one reference on patients with chronic diabetic neuropathy which reported on outcomes such as nerve function and pain, which are unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One study (Rai et al., 1990) was a double-blind, parallel-group, randomised controlled trial (RCT) on the efficacy of 24-week oral administration of acetyl-L-carnitine in 36 patients with dementia of the Alzheimer type. The study by Spagnoli et al. (1991) was a double-blind, parallel-group RCT on the efficacy of one year oral administration of acetyl-L-carnitine on functional and cognitive outcomes in 130 pharmacologically treated patients with Alzheimer’s disease. Another study (Passeri et al., 1988) was a double-blind RCT in 30 elderly subjects suffering from mild cognitive impairment (Mini Mental State Examination (MMSE) <22) on the efficacy of three months administration of acetyl-L-carnitine on intellectual and behavioural deficiencies. The study by Malaguarnera et al. (2008), was a double-blind RCT in 96 elderly subjects with chronic fatigue syndrome (according to Holmes and Fukuda criteria) on the efficacy of 180-day administration of acetyl-L-carnitine on fatigue, and on cognitive and functional status. The Panel considers that the evidence provided does not establish that results obtained in studies in patients with Alzheimer’s disease, cognitive impairment or chronic fatigue syndrome can be extrapolated to the general population with regard to normal cognitive function.
An in vitro study (Abdul et al., 2006) investigated the effects of acetyl-L-carnitine on amyloid-beta peptide-mediated damage of neuronal cells. The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of acetyl-L-carnitine consumption on normal cognitive function in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of acetyl-L-carnitine and contribution to normal cognitive function.
Warunki i możliwe ograniczenia stosowania oświadczenia
2-4g acetyl-L-carnitine daily for up to 12 months is suggested based on trials.
