ID 1716 - Białko tuńczyka pasiastego

PL: Białko tuńczyka pasiastego
EN: Bonito protein peptide
Pdf: bonito protein peptide

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is bonito protein peptide.
Dried bonito (type of fish) is a traditional Japanese seasoning known as Katsuobusi. Bonito protein peptide is obtained after hydrolysis with thermolysin (or digestion) of bonito muscle. From the unknown number of peptides present in the digest, eight peptides have been isolated that could inhibit the angiotensin-converting enzyme (ACE) in vitro. The amino acid sequences of these ACE-inhibitory peptides are Ile-Lys-Pro-Leu-Asn-Tyr, Ile-Val-Gly-Arg-Pro-Arg-His-Gln-Gly, Ile-Trp-His-His-Thr, Ala-Leu-Pro-His-Ala, Phe-Gln-Pro, Leu-Lys-Pro-Asn-Met, Ile-Tyr, and Asp-Tyr-Gly-Leu-Tyr-Pro. Of these, Leu-Lys-Pro-Asn-Met (or LKPNM) is considered the main “active” ingredient (IC50 = 2.4 μmol/L). Thermolysin-digested dried bonito containing 0.17 % (w/w) of LKPNM, also known as “Katsuobushi Oligopeptide (KO)”, is available as a food ingredient on the Japanese market (Yokoyama et al., 1992; Fujita et al., 2000).
The Panel considers that the food constituent, bonito protein peptide (or LKPNM, amino acid sequence Leu-Lys-Pro-Asn-Met), which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “natural blood pressure support”. 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 the 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 above 140 mmHg (systolic) and/or 90 mmHg (diastolic), may compromise the normal arterial and cardiac function.
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

Seven references were provided for the substantiation of this claim. Four of these provide data on the angiotensin-converting enzyme (ACE) inhibitory activity of bonito protein digest in vitro and/or antihypertensive effects of this digest in spontaneously hypertensive rats (SHR). The remaining three references reported on human intervention studies which assessed the effects of Katsuobushi Oligopeptide (KO)” standardised by its LKPNM content on blood pressure (Fujita et al., 1997a; 1997b; 2001).
A randomised crossover study was performed in 35 borderline and mildly hypertensive Japanese subjects with an average blood pressure level of 150/100 mmHg (Fujita et al., 1997a). No information on use of antihypertensive drugs was provided in the publication. During active intervention, subjects received 3 g per day of KO, yielding an intake of 5 mg per day of LKPNM, for a period of eight weeks. Half of the subjects (group 1) took the test food during the first 8-week period, and the other half (group 2) during the second 8-week period. During control periods, no placebo supplement or other type of intervention were provided. Blood pressure values in the last week of the test food period were compared to those of the control period in the 30 subjects who completed the study. No biological parameters of the renin-angiotensin system were assessed to check ACE-inhibition. The Panel notes that the sample size was small, that this study was neither blinded nor placebo controlled, that carry-over effects were not assessed, and that antihypertensive medication use in the study subjects was not reported. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The same investigators also conducted a 2x5-week randomised crossover study (Fujita et al., 1997b) in which 37 borderline and mildly hypertensive Japanese subjects with an average blood pressure of 151/100 mmHg consumed a KO-containing soup, followed by a placebo soup, or vice versa. No information on use of antihypertensive medications was provided. During active treatment, subjects had a daily intake of 3 g/d of KO, providing 5 mg/d of LKPNM. There were no drop-outs during the study. The Panel notes that no direct statistical comparisons were made between the intervention and the placebo periods, and that no information on use of antihypertensive medications by the study subjects was provided. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
Fujita et al. (2001) obtained a “stronger KO” (S-type KO) by ultra-filtration that contained 0.34 % (w/w) of LKPNM and had a two-fold higher antihypertensive activity in spontaneously hypertensive rats after oral administration, compared with the original KO. The effect of 1.5 g per day of S-type KO (in tablets) on blood pressure was tested against placebo in a randomised, double-blind cross-over study in 65 borderline and mildly hypertensive Japanese subjects with an average blood pressure level of 149/93 mmHg. No information on use of antihypertensive medications was provided. Four subjects dropped out during the study. No biological parameters of the renin-angiotensin system were assessed to check ACE-inhibition. The Panel notes that no direct statistical comparisons were made between the intervention and the placebo periods, and that no information on the use of antihypertensive medications by the study subjects was provided. The Panel considers that no conclusions can be drawn form this reference for the scientific substantiation of the claimed effect.
Four references provided data on the ACE-inhibitory activity of bonito protein digest in vitro (Yokoyama et al., 1992; Fujita et al., 2000) and/or on the antihypertensive effects of this digest in spontaneously hypertensive rats (Fujita et al., 1995; Fujita and Yoshikawa, 1999). The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and evidence provided in animal and in vitro studies alone is not sufficient to predict the occurrence of an effect of bonito protein peptide (LKPNM) on blood pressure in humans.
In weighing the evidence, the Panel took into account that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided, and that results from the animal and in vitro studies submitted are not sufficient to predict the occurrence of an effect of bonito protein peptide (LKPNM) on blood pressure in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of bonito protein peptide (or LKPNM, amino acid sequence Leu-Lys-Pro-Asn-Met) and maintenance of normal blood pressure.

Warunki i możliwe ograniczenia stosowania oświadczenia

The recommended daily dosage: 1500 mg bonito protein powder (Sarda orientalis)