Scientific Opinion on the substantiation of health claims related to
“αS1-casein tryptic hydrolysate” and alleviation of psychological stress
(ID 656, 1819, 4253) pursuant to Article 13(1) of Regulation (EC)
No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
S1-Casein tryptic hydrolysate
health claims
psychological stress
1. Charakterystyka żywności / składnika
The food constituents that are the subject of the health claims are “lactium milk protein hydrolysate”, “lactium-peptide compound” and “hydrolysat de protéines de lait: milk protein hydrolysate concentrated with 1,7 % of alphaS1 decapeptide (=lactium)”.
In the context of the references provided, the Panel notes that the food constituent which is the subject of the health claims is a specific commercial preparation of αS1-casein tryptic hydrolysate. The milk protein hydrolysate is released during the tryptic breakdown of the milk protein αS1-casein. The main peptide in the specific αS1-casein tryptic hydrolysate that is the subject of the health claim is αS1-CN (f91-100), a decapeptide called α-casozepine (Miclo et al., 2001).
The Panel considers that the food constituent, the specific αS1-casein tryptic hydrolysate, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effects are “helps to calm mind”, “mental state and performance”, and “stress”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and from the references provided, the Panel assumes that the claimed effects refer to alleviation of psychological stress. Psychological stress can be measured by established methods.
The Panel considers that alleviation of psychological stress might be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Łagodzenie stresu
Six references were provided for the scientific substantiation of the claim, including two posters with insufficient information regarding the study design, methodology and statistical analyses for a complete scientific evaluation. Another reference, which was not accessible to the Panel after every reasonable effort was made to retrieve it, was an unpublished double-blind, placebo-controlled, parallel trial using αS1-casein tryptic hydrolysate. One reference reported on in vitro and animal
studies where “αS1-casein tryptic hydrolysate” was administered via intra-peritoneal injections, which is not a relevant route for human nutrition. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A double-blind, randomised controlled trial (RCT) was conducted in 42 healthy males who ingested three times, 12 hours apart, two capsules containing either 200 mg of “αS1-casein tryptic hydrolysate” (total=400 mg) or a placebo (bovine skimmed milk powder) (Messaoudi et al., 2005). On the test day, two hours after the administration of the third dose of “αS1-casein tryptic hydrolysate”, subjects undertook the Stroop Test and, after a 30-min rest, a Cold Pressor Test (CPT). Outcome measures were changes in systolic and diastolic blood pressure, heart rate and plasma cortisol concentrations in response to the Stroop and/or the CPT. The Panel notes that changes in physiological parameters are not direct measures of psychological stress, and are not sufficient on their own to indicate an alleviation of psychological stress. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In a double-blind, cross-over RCT, 63 females who reported at least one of the symptoms of anxiety, sleep problems and general fatigue received 150 mg/day of “αS1-casein tryptic hydrolysate” and a placebo (bovine skimmed milk powder) for 30 days each with a three-week wash-out period in between (Kim et al., 2007). The outcome measure was a new 44-item questionnaire developed by combining two existing anxiety scales (Hamilton Anxiety Scale and Ferreri Anxiety Rating Diagram), and was assessed at days 0, 15 and 30 of each intervention period. The Panel notes that no information was provided on the validity and reliability of this novel questionnaire to directly and specifically measure psychological stress, and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of “αS1-casein tryptic hydrolysate” and alleviation of psychological stress.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, the specific αS1-casein tryptic hydrolysate, which is the subject of the health claim, is sufficiently characterised.
The claimed effects are “helps to calm mind”, “mental state and performance”, and “stress”. The target population is assumed to be the general population. Alleviation of psychological stress might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of “αS1-casein tryptic hydrolysate” and alleviation of psychological stress.
