ID 4682 -
Arginina
PL: Arginina
EN: Arginin
Pdf: L-arginine
Oświadczenie (2)
- spermatogenezy
- Wspieranie spermatogenezy i lokalnych mikrokrążenia w obrębie miednicy
- erekcji
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is L-arginine.
Arginine is an alpha-amino acid present in foods from animal and vegetable origin. The L-form is the most commonly found form in nature and in food supplements. L-arginine is also known as (S)-2- amino-5-guanidinopentanoic acid and (S)-2-amino-5-[(aminoiminomethyl)amino] pentanoic acid. The terms L-arginine and arginine are frequently used interchangeably. The content of L-arginine in foods can be measured by established methods.
Arginine is a conditionally indispensable amino acid provided by mixed dietary protein intakes from different sources. Arginine can also be consumed in the form of food supplements as L-arginine.
The Panel considers that the food constituent, L-arginine, which is the subject of the health claims, is sufficiently characterised.
2.8. Utrzymanie prawidłowej erekcji (ID 649, 4682)
The claimed effects are “erection” and “supporting spermatogenesis and local pelvic microcirculation”. The Panel assumes that the target population is the general male population.
In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effects refer to the maintenance of normal erectile function.
The Panel considers that maintenance of normal erectile function is a beneficial physiological effect.
2.9. Udział w prawidłowej spermatogenezie (tworzeniu plemników) (ID 650, 4682)
The claimed effects are “spermatogenesis” and “supporting spermatogenesis and local pelvic microcirculation”. The Panel assumes that the target population is the general male population.
In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effects refer to normal spermatogenesis.
The Panel considers that contribution to normal spermatogenesis is a beneficial physiological effect.
3.5. Utrzymanie prawidłowej erekcji (ID 649, 4682)
The references provided for the scientific substantiation of the claim included general reviews, a web page, a monograph, human intervention studies, animal studies and in vitro experiments on food/food constituents other than L-arginine, and/or effects other than erectile function (i.e. oligoasthenospermia, asthenospermia and sperm motility). The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
Two human intervention studies examined the effect of L-arginine glutamate or L-arginine aspartate alone or in combination with other compounds (i.e. yohimbine hydrochloride and pine bark extract) on erectile function. The Panel considers that no conclusions can be drawn from studies using a fixed combination for the substantiation of a claim on arginine alone.
Chen et al. (1999), in a randomised, double-blind, placebo-controlled study investigated the ability of L-arginine to improve erections in 50 male subjects with confirmed organic erectile dysfunction of >6 months duration. The first two weeks of the study were a single-blind, placebo run-in phase; at the end of this period the patients were randomised and received 5 g of L-arginine monohydrochloride or placebo daily for six weeks. A penile haemodynamic test assessing peak systolic velocity, end diastolic velocity and resistance index was used as an objective measure of erectile function. Subjective measures included the O'Leary questionnaire, which contained 11 questions on sexual drive, erectile function and overall sexual satisfaction, and a questionnaire on sexual function which addressed the number and quality of the erections, libido and sexual performance. No significant differences between groups were observed in either the objective measures or the subjective estimates of erectile function. The Panel notes that this study does not show an effect of L-arginine consumption on erectile function.
Klotz et al. (1999), in a randomised, placebo-controlled, cross-over study, investigated the effects of 500 mg L-arginine three times daily in 32 subjects with erectile dysfunction of >12 months duration. Between changes in treatment, the subjects had a wash-out phase of one week. Efficacy was assessed using the validated Köln Questionnaire of Erectile Dysfunction (KEED). No significant differences on erectile function between groups were observed. The Panel notes that this study does not show an effect of L-arginine consumption on erectile function.
The remaining reference was a study on the long-term oral administration of L-arginine on rat erectile response (Moody et al., 1997). The Panel considers that while effects shown in animal studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of arginine consumption on normal erectile function in humans.
In weighing the evidence, the Panel took into account that the two human intervention studies which investigated the effect of L-arginine consumption on erectile function did not show a significant effect of arginine on erectile function.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and maintenance of normal erectile function.
3.6. Udział w prawidłowej spermatogenezie (tworzeniu plemników) (ID 650, 4682)
The references provided for the scientific substantiation of the claim included general reviews, a web page, a monograph, human intervention studies, animal studies and in vitro experiments on foods/food constituents other than L-arginine, and/or effects other than spermatogenesis (i.e. erectile function). The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
One human intervention study (De Aloysio et al., 1982) investigated the effect of arginine aspartate (providing arginine and aspartic acid) in subjects with asthenospermia or oligoasthenospermia. The Panel considers that no conclusions can be drawn from a study using a fixed combination for the substantiation of a claim on arginine alone.
In a randomised human intervention study by Aydin et al. (1995), 45 subjects with various degrees of oligospermia and asthenospermia were treated with L-arginine (2x5 g/day, n=15), the anti-inflammatory agent indomethacin (75 mg/day, n=15) or the enzyme kallikrein (100 Ku/day, n=15) for three months to encompass a complete cycle of spermatogenesis. The Panel notes the absence of an appropriate control group in this study, and considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
In the study described by Scibona et al. (1994) L-arginine-HCL (80 mL of 10 % L-arginine-HCL administered for 6 months daily) was administered to 40 asthenospermic subjects to assess its effects on sperm motility. The Panel notes the absence of a control group in this study, and considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claimed effect.
In an in vitro study the effects on sperm motility of adding L-arginine to sperm cell suspensions from idiopathic or diabetic asthenozoospermic subjects was assessed (Morales et al., 2003). The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of arginine consumption on normal spermatogenesis in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L-arginine and contribution to normal spermatogenesis.
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