ID 502 - Kwas dokozaheksaenowy, Kwas eikozapentaenowy

PL: Kwas dokozaheksaenowy, Kwas eikozapentaenowy
EN: DHA+EPA - long chain omega 3 fatty acids
Pdf: eicosapentaenoic acid

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituents which are the subject of the health claims are mixed long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA), namely docosahexaenoic acid (DHA) in combination with eicosapentaenoic acid (EPA) and, for ID 511, with docosapentaenoic acid (DPA).
The n-3 LCPUFA EPA, DHA and DPA are recognised nutrients and are measureable in foods by established methods. They are well absorbed when consumed in the form of triglycerides. This evaluation applies to EPA, DHA and, for ID 511, DPA from all sources with appropriate bioavailability in the specified amounts.
The Panel considers that the food constituents, EPA, DHA and DPA, which are the subject of the health claims are sufficiently characterised.

2.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 502)

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

3.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 502)

The background literature provided includes various statements by authoritative bodies that advocate fish intake (1-2 times per week) and/or EPA plus DHA intake (~250-500 mg/day) for the prevention of coronary heart disease. The statements are based on scientific evidence for a beneficial effect of EPA plus DHA on cardiac mortality. None of the statements recommend increased intake of EPA plus DHA for their antihypertensive properties.
The literature presented refers to three meta-analyses (Appel et al., 1993; Morris et al., 1993; Geleijnse et al., 2002), which include two of the individual clinical trials provided (Knapp, 1989; Schmidt, 1992) and all are considered pertinent to the substantiation of the claim.
Appel et al. (1993) conducted a meta-analysis of 17 clinical trials on the effects of dietary n-3 fatty acids (mainly EPA plus DHA) on BP. Systolic BP was significantly reduced in two out of the 11 trials conducted in normotensive subjects, and in two out of the six trials conducted in untreated hypertensive subjects. Pooled estimates for systolic BP were -1.0 mmHg (95% CI: -2.0 to 0.0) in normotensive subjects and -5.5 mmHg (95% CI: -8.1 to -2.9) in hypertensive subjects. Daily doses of n-3 fatty acids were generally high (>3 g in 11 trials).
Morris et al. (1993) performed a meta-analysis of 31 clinical trials investigating the effects of fish oil consumption (mainly EPA plus DHA) on BP. Systolic BP was reduced on average by -3.0 mmHg (95% CI: -4.5 to -1.5). When grouped by EPA plus DHA dose, effects on systolic BP were -1.3 mmHg at ≤ 3 g/d, -2.9 mmHg at 3.3 to 7 g/d, and -8.1 mmHg at 15 g/d. Both EPA and DHA were related to BP response. Systolic BP was not reduced in "healthy" (i.e., normotensive and normocholesterolemic) subjects, i.e. -0.4 mmHg for a mean fish oil dose of 4.2 g per day. Significant BP reductions were found in hypertensive subjects (-3.4 mmHg at 5.6 g/d of EPA plus DHA) and in hypercholesterolaemic patients (-4.4 mmHg at 4.0 g/d of EPA plus DHA).
More recently, Geleijnse et al. (2002) performed a meta-analysis of 36 randomised controlled trials. Daily doses of fish oil (mainly EPA plus DHA) were <1.0 g in one trial, 1.0-1.9 g/d in five trials, 2.0-2.9 g/d in four trials, and 3.0–15.0 g/d in 26 trials, with a median dose of 3.7 g/d. Fish oil reduced systolic BP by -2.1 mmHg (95% CI: -3.2 to -1.0). Restricting the analysis to randomised controlled trials that were double-blind yielded a systolic BP estimate of -1.7 mmHg (95% CI: -3.1 to -0.3). Effects of EPA plus DHA intake on systolic BP were larger in older (>45y of age) subjects (-2.7 mmHg) and in hypertensive subjects (-3.7 mmHg).
Clinical trials on the effects of low doses of EPA plus DHA on BP are lacking. In a recent trial by Murphy et al. (2007), 86 overweight subjects with high serum triglyceride concentrations were randomised to 1 g of EPA plus DHA daily (by means of enriched foods) or placebo, for 6 months. Dietary intervention with EPA plus DHA improved various cardiovascular risk factors, but did not significantly affect BP (Murphy et al., 2007).
Potential mechanisms by which fish oil could reduce BP were described by Howe (1997). The review refers to animal experiments and results from meta-analyses of clinical trials (Appel et al., 1993; Morris et al., 1993). Howe (1997) concluded that there is uncertainty about the antihypertensive effects of EPA and DHA and about underlying mechanisms in animal models. He also stated that the extent of BP reduction depends on the initial BP level and on the dose of very long chain n-3 fatty acids so that clinically significant effects may be expected in hypertensive but not normotensive subjects, given a mean dose of ~3 g of EPA plus DHA per day.
From the evidence provided, the Panel considers that high doses of EPA + DHA ( 3 grams per day) have a short-term effect on systolic BP in subjects with untreated hypertension (~3-5 mmHg decrease in systolic BP; Mancia et al., 2007), and may have smaller, but statistically significant, effects in normotensives (~1 mmHg decrease in systolic BP).
The Panel concludes that a cause and effect relationship has been established between the consumption of EPA and DHA and the reduction of blood pressure.

4.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 502)

The Panel considers that the following wording reflects the scientific evidence: “DHA and EPA contribute to the maintenance of normal blood pressure”.

5.1. Utrzymanie prawidłowego ciśnienia tętniczego (ID 502)

The Panel considers that intakes of EPA and DHA of about 3 g/d are required to obtain the claimed effect. The target population is adult men and women.

Warunki i możliwe ograniczenia stosowania oświadczenia

3 to 4 g per day