ID 536 - Kwas dokozaheksaenowy, Kwas eikozapentaenowy

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

Oświadczenie (2)

1. Charakterystyka żywności / składnika

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

2.8. Poprawa nastroju (ID 536)

The claimed effect is “mood”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided, the Panel assumes that the claimed effect refers to enhancement of mood. Mood is a well-defined psychological construct and can be measured by validated tests.
The Panel considers that enhancement of mood might be a beneficial physiological effect.

3.1. Poprawa nastroju (ID 536)

Among the references provided were narrative reviews which mostly reported on the use of omega-3 fatty acids either alone or in conjunction with pharmacological intervention in depression. These studies did not describe the food constituent under investigation or did not address a relevant endpoint. In addition, a number of references reported on studies which were carried out in pregnant women or in patient groups with post-partum depression, major depressive disorder which required inpatient treatment, violence disorders, bipolar disorder and schizophrenia. The Panel considers that the evidence provided does not establish that results obtained in studies in subjects with post-partum depression, major depressive disorder, violence disorders, bipolar disorder and schizophrenia can be extrapolated to the general population with respect to mood. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One systematic review carried out by Schachter et al. (2005) for the Agency for Healthcare Research and Quality (AHRQ) addressed, inter alia, the question of the protective value of n-3 fatty acids with respect to mental health. Three intervention studies, six observational studies and three cross-national ecological studies met the authors' inclusion criteria, and were included in the review. One of the randomised controlled trials assessed the risk of post-partum depression using a supplement containing DHA only, rather than DHA and EPA which is the subject of the claim. The other two intervention studies were based on a dietary change to increase fish consumption, but DHA and EPA intakes were not measured. There were four observational studies on the relationship between fish consumption and depressed mood or prevalence of depression, and three cross-national studies investigating the association of seafood consumption with the prevalence of post-partum depression or depression. The Panel notes that the only epidemiological study in the systematic review, which calculated DHA and EPA intakes on the basis of self-reported fish consumption, showed no association between intake of these fatty acids and prevalence of depression.
Two of the human studies provided were intervention studies (Fontani et al., 2005a; 2005b). One of these studies (Fontani et al., 2005a) investigated the effects of diet and fish oil (containing EPA and DHA) supplementation on an index of mood state in addition to blood lipids, insulin and various biomarkers of inflammatory processes. This study was performed in 33 subjects who were divided into two groups following an open-label, parallel group design. Both groups followed a controlled diet which differed in amount of carbohydrates and proteins (55/15 E% (N diet group, n=17) vs. 40/30 E% (Z diet group, n=16) respectively, 30 E% fat in both). In each diet group a double-blind cross-over design was applied: one sub-group received placebo (olive oil) for 35 days and then fish oil supplementation for another 35 days, while the other sub-group started with fish oil supplementation followed by placebo. Mood state was measured using the Profile of Mood States (POMS) which consists of five negative scales (anger, anxiety, fatigue, confusion, depression) and one positive scale
(vigour). The Panel notes that the statistical analysis employed was not appropriate for the treatment of a cross-over design, and that no corrections for multiple comparisons were made. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The other study by Fontani et al. (2005b) used a parallel design in which 33 subjects received EPA and DHA as fish oil for 35 days, and a second group of 16 subjects received a placebo consisting of olive oil capsules for the same period. Mood state was measured on the first and last day of the intervention using the POMS. The Panel notes that the statistical analysis only evaluated within group data, and did not perform comparisons between groups. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
Of the three observational human studies provided, two (Edwards et al., 1998; Tanskanen et al., 2001) were included in the systematic review by Schachter et al. (2005). The observational study by Mamalakis et al. (2002) investigated the association between adipose tissue fatty acid content and depression in 139 participants with a mean age of 39 years. Subjects underwent physical examination and adipose tissue extraction (by aspiration of subcutaneous tissue samples), and completed the Zung Self-rated Depression Scale (translated). The Panel notes that dietary intakes of EPA and DHA were not estimated, that adipose tissue EPA and DHA concentrations are usually only moderately associated with the consumption of EPA and DHA, and that an observational cross-sectional study does not provide evidence on a causal relationship between the intake of DHA and EPA and mood. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel notes that no intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect, and that the one observational study which evaluated dietary intakes of EPA and DHA showed no association between the consumption of DHA and EPA and prevalence of depression.
The Panel concludes that a cause and effect relationship has not been established between the consumption of DHA and EPA and enhancement of mood.

Warunki i możliwe ograniczenia stosowania oświadczenia

General Population. Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day)