1478.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to a C12-peptide (Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val-Phe-Gly-Lys) and maintenance of normal blood pressure (ID 1483, 3130) 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: C12-peptide   blood pressure   health claims  
ID:    3130      1483  
Produkty: Peptyd Fenyloalanina-Fenyloalanina-Walina-Alanina-Prolina-Fenyloalanina-Prolina-Glutamina-Walina-Fenyloalanina-Glicyna-Lizyna  

1. Charakterystyka żywności / składnika

The food that is the subject of the claim is “C12-peption”, defined in the conditions of use as milk protein-derived hydrolysate.
From the references provided, the Panel assumes that the food refers to a dodecapeptide obtained from the hydrolysis of the milk protein casein with trypsin with the following amino acid sequence: Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val-Phe-Gly-Lys (Karaki et al., 1990).
The Panel considers that the food constituent, a C12-peptide with the following amino acid sequence Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val-Phe-Gly-Lys, which is the subject of the claim is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “vascular health”. The Panel assumes the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to maintenance of normal blood pressure.
Blood pressure is the pressure (force per unit area) exerted by circulating blood on the walls of blood
vessels. Elevated blood pressure, by convention 140 mmHg (systolic) and/or 90 mmHg (diastolic), may compromise the normal function of the arteries.
The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Wpływ na utrzymanie prawidłowego ciśnienia krwi

Thirty eight references were provided in relation to this claim. Most of the references addressed endpoints unrelated to the claimed effect or used foods other than a C12-peptide with the following amino acid sequence Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val-Phe-Gly-Lys or milk protein-derived hydrolysateincluding a dodecapeptide. The Panel considers that no conclusions can be drawn from these references for the substantiation of the claim.
Only three references were considered as likely related to the food, one animal study in spontaneously hypertensive rats (Karaki et al., 1990), a pilot acute randomised, double-blind, crossover intervention in humans (Townsend et al., 2004) and a randomised double-blind controlled trial in humans (Cadee et al., 2007).
In the pilot, randomised, double-blind, crossover intervention by Townsend et al. (2004), 10 hypertensive men received three different single day treatments in a random order: 100 mg/d of hydrolysed bovine milk protein (designated C12 peptide), 200 mg/d of the same hydrolysate, and placebo. Blood pressure was determined up to six hours after consumption of the test foods and placebo. No significant differences between treatments on blood pressure were observed. Since the amino acid sequence of the C12 peptide administered is not reported, the Panel is uncertain how the food constituent used in this study relates to the food constituent which is the subject of the health claim. In the study by Cadee et al. (2007), 54 pre-hypertensive subjects were randomised to consume 3.8 g/d of a hydrolysate of bovine milk protein containing 6.3% of a dodecapetide or placebo for four weeks. Blood pressure was determined weekly during the treatment period (four weeks) and two weeks after cessation. A total of 48 subjects completed the study. The Panel notes that the statistical comparison between the intervention and control groups with regard to changes in blood pressure during the intervention was not reported. In addition, since the amino acid sequence of the C12 peptide administered is not reported, the Panel is uncertain how the food constituent used in this study relates to the food constituent which is the subject of the health claim. The Panel considers that no scientific conclusions can be drawn from these studies for the substantiation of the claim.
One animal study in spontaneously hypertensive rats (Karaki et al., 1990) reported on the effects of C-12 peptide (Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val-Phe-Gly-Lys) consumption on blood pressure. The Panel considers that the evidence provided in this animal study is not sufficient to predict the occurrence of an effect of the C-12 peptide consumption on maintenance of normal blood pressure in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a C12-peptide with the amino acid sequence Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val- Phe-Gly-Lys and maintenance of normal blood pressure.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food, a C12-peptide with the following amino acid sequence Phe-Phe-Val-Ala-Pro-Phe- Pro-Glu-Val-Phe-Gly-Lys, which is the subject of the claim is sufficiently characterised.
The claimed effect is “vascular health”. The target population is assumed to be the general population. Maintenance of normal blood pressure is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a C12- peptide with the amino acid sequence Phe-Phe-Val-Ala-Pro-Phe-Pro-Glu-Val-Phe-Gly-Lys and maintenance of normal blood pressure.