ID 1155 - Orzech włoski

PL: Orzech włoski
EN: JUGLANS REGlA L.
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Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food that is the subject of the health claims is walnuts.
Walnuts are seeds from the walnut tree (genus Juglans) of which about 20 different species are known in different parts of the world. Walnuts are drupes, rather than nuts. One of the most popular varieties of walnut is the Persian or English walnut, which has a large seed and a thinner shell, yielding more edible walnut meat by weight than other species. Black walnuts are another commonly sold walnut species, as are white walnuts, also called butternuts. The nut kernels contain about 57-65 % fat, of which about 3-6 % are saturated fatty acids (SFAs), 9-15 % are monounsaturated fatty acids (MUFAs), and 35-47 % are polyunsaturated fatty acids (PUFAs) (33-38 % linoleic acid (LA), and 2-9 % alpha-linolenic acid (ALA)). The nut kernels also contain about 5-7 % fibre, of which about 25 % is soluble fibre, 15-29 % protein, and small amounts of plant sterols and other phytochemicals. The Panel notes the variation in terms of macronutrient composition between different types of walnuts.
The Panel considers that the food, walnuts, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.

2.2. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 1155, 1157)

The claimed effects are “well-balanced ratio of n-3- to n-6-fatty acids: artery and heart health lipid metabolism”, and “artery health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the improvement of endothelium-dependent vasodilation.
The Panel considers that a sustained improvement of endothelium-dependent vasodilation may be a beneficial physiological effect.

3.2. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 1155, 1157)

The references provided for the scientific substantiation of the claim included narrative reviews, consensus opinions, and epidemiological and intervention studies on the effects of PUFAs, including ALA and LA, on health outcomes other than improvement of endothelium-dependent vasodilation (e.g. blood lipids, blood pressure and cardiovascular risk). In addition, some epidemiological studies which investigated the association between nut consumption, including walnuts, on health outcomes not related to the claimed effect (e.g. blood lipids, blood pressure and cardiovascular risk) were provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
In a randomised, controlled cross-over trial by Ros et al. (2004) 21 untreated hypercholesterolaemic men and women consumed a Mediterranean type diet low in saturated fatty acids (about 5 % energy) and a diet of similar energy and fat content (33 E%) in which 40-65 g/day of walnuts contributed to about 18 % total energy, and replaced approximately 32 % of the energy obtained from monounsaturated fat (olive oil, olives and avocados) in the control diet, for 4 weeks each without a wash-out period. There was a 4-week run-in period to allow for diet and weight stabilisation. The order of the diets was randomised. After each intervention, ultrasound measurements of brachial artery vasomotor function were taken. Endothelium-dependent vasodilation (EDV) was the primary outcome of the study. Endothelium-independent vasodilation (EIDV) was evaluated by administering 0.4 mg sublingual glyceryl trinitrate prior to the measurement, and was used as internal control. Reproducibility of measurements over one month was documented in 15 healthy volunteers. The
repeatability coefficient was 5.16, and the mean SD difference between EDV values was
0.52 2.66 %. It was calculated that 19 subjects were needed to detect a mean difference in EDV of
2 %, with a type I error of 5 % and a power 90 %. A total of 20 subjects completed the study and suitable brachial artery ultrasound measurements were available for 18 subjects. Compared with the
Mediterranean diet, the walnut diet significantly improved EDV (from 3.6 3.3 % to 5.9 3.3 %, a relative increase of 64 %), and significantly reduced concentrations of vascular cell adhesion molecule-1 (VCAM-1), which is a marker of endothelial activation. EIVD and concentrations of intercellular adhesion molecule-1 (ICAM-1) were not significantly different between diets. The walnut diet significantly decreased total cholesterol (-4.4±7.4 %) and LDL-cholesterol (-6.4±10.0 %) concentrations. Changes in EDV significantly correlated with changes in the total/HDL-cholesterol ratio. There was no evidence of carry-over effects between treatment periods. The Panel notes that this study provides evidence for a positive and sustainable effect of walnut consumption on endothelium-dependent vasodilation.
In a randomised, controlled cross-over trial by Ma et al. (2010), 24 type 2 diabetic subjects aged 30-75 years on stable medication use for at least three months (17 on blood pressure-lowering medication, 13 on cholesterol-lowering medication, 10 on oral antidiabetic medication) consumed a walnut-enriched ad libitum diet, and an ad libitum diet without walnuts, for 8 weeks each in a random order with an 8-week wash-out period in between, and after a 4-week run-in period to allow for diet and weight stabilisation. During the walnut period, subjects consumed 56 g English walnuts daily. EDV was the primary outcome of the study. A stimulus-adjusted response measure was used as internal control. The sample size was determined to allow for about 20 % attrition and
non-compliance, and to provide 80 % power to detect a minimal difference of 2.5 % in EDV between treatments, with a maximum allowable type I error of 5 %. A total of 96 % of subjects
complied with the consumption of walnuts (defined as intake of 80 % of the assigned dose). EDV improved significantly after consumption of the walnut-enriched diet as compared with the ad libitum
diet without walnuts (2.2 1.7 % vs. 1.2 1.6 %, p=0.04), whereas no significant changes between groups were observed in the stimulus-adjusted response measure. No significant differences were observed between diets with respect to changes in blood lipid profile, body weight, blood glucose control or insulin sensitivity, whereas a significant decrease in systolic and diastolic blood pressure was observed in the walnut diet compared to the control diet. The Panel notes that the results of this study are consistent with findings in human intervention studies in untreated subjects on the effect of walnut consumption on endothelium-dependent vasodilation.
In a randomised cross-over study, Cortes et al. (2006) investigated whether the addition of walnuts or olive oil to a fatty meal had different effects on post-prandial vasoactivity, lipoproteins, markers of oxidation and endothelial activation, and plasma asymmetric dimethylarginine (ADMA). Endothelium-dependent vasodilation was the primary outcome of the study. A total of 12 healthy subjects and 12 subjects with hypercholesterolaemia who received no pharmacological treatment were randomised to two high-fat meal sequences (separated by one week) to which 25 g olive oil or 40 g walnuts had been added. Both test meals contained 63 % of the energy as fat (80 g fat) and 35 E% saturated fatty acids. Ultrasound measurements of brachial artery endothelial function were performed
after fasting and 4 h after test meals. In both study groups, flow-mediated dilation (FMD) was lower after the olive oil meal than after the walnut meal (p=0.006). Flow-independent dilation and plasma ADMA concentrations were unchanged, and concentrations of oxidised low-density lipoproteins decreased (p=0.051) after both meals. The plasma concentrations of soluble inflammatory cytokines, and of adhesion molecules, decreased (p<0.01) independently of meal type, except for E-selectin, which decreased significantly more after the walnut meal. E-selectin is an adhesion molecule involved in the early steps of monocyte recruitment to the endothelium. The Panel notes that this study is an acute study, and does not allow conclusions to be drawn on the sustainability of the effects of the consumption of walnuts on EDV.
In weighing the evidence, the Panel took into account that one intervention study in healthy subjects, adequately powered and controlled, showed a sustained effect of the consumption of walnuts on endothelium-dependent vasodilation, that the results of one additional intervention study in type 2 diabetic subjects on blood pressure-lowering, cholesterol-lowering, and/or oral antidiabetic medication are consistent with these findings, and that an acute intervention study also showed a positive effect of the consumption of walnuts on endothelium-mediated vasodilation.
The Panel concludes that a cause and effect relationship has been established between the consumption of walnuts and improvement of endothelium-dependent vasodilation.

4.1. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 1155, 1157)

The Panel considers that the following wording reflects the scientific evidence: “Walnuts contribute to the improvement of endothelium-dependent vasodilation”.

5.1. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 1155, 1157)

The Panel considers that in order to obtain the claimed effect, 30 g of walnuts should be consumed daily. These amounts can be consumed in the context of a balanced diet. The target population is the general population.

Warunki i możliwe ograniczenia stosowania oświadczenia

30 g/day daily