ID 1506 - Flawonole z kakao

PL: Flawonole z kakao
EN: Cocoa flavanols
Pdf: cocoa flavanols

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituents that are the subject of the health claims are cocoa in chocolate, polyphenols and cocoa flavanols.
Cocoa (Theobroma cacao L.) contains a wide range of polyphenols, such as flavan-3-ols. No further information is provided on the nature and intakes of polyphenols in cocoa or dark chocolate to obtain the claimed effect. The conditions of use specify foods containing minimum 30 % of daily intakes of about 3000 to 5000 ORAC units per day (ID 652, 3143), which refers to the oxygen radical absorbance capacity (ORAC) measured in vitro in the food. An antioxidant capacity assay such as ORAC is not an acceptable way of characterising a food/food constituent which is the subject of a health claim because it is a non specific assay for substances capable of protecting a red photoreceptor pigment (β-phycoerythrin) from oxidation. The ORAC value of a food is not relevant for establishing a cause and effect relationship between the bioactive constituent (e.g. polyphenols) and the possible health effect. Therefore, the Panel considers that cocoa polyphenols per se are not sufficiently characterised, nor are the conditions of use specified appropriately.
The flavanol (i.e. procyanidins and catechins) content in cocoa, however, is measurable in foods by established methods and conditions of use are provided for flavanols naturally occurring in cocoa. This opinion will apply to flavanols naturally present in cocoa.
The Panel considers that the food constituent, cocoa flavanols, that is the subject of the health claims is sufficiently characterised.

2.1. Ochrona lipidów przed uszkodzeniem oksydacyjnym (ID 652, 1372, 1506, 3143)

The claimed effects are “antioxidant properties” and “oxidative stress reduction”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and the references provided, the Panel assumes that the claimed effect relates to the protection of body lipids from oxidative damage.
Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g. respiratory chain) and as a consequence of exposure to exogenous factors (e.g. radiation, pollutants). These reactive intermediates damage DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers such as antioxidant nutrients.
The Panel considers that the protection of lipids from oxidative damage may be a beneficial physiological effect.

3.1. Ochrona lipidów przed uszkodzeniem oksydacyjnym (ID 652, 1372, 1506, 3143)

The majority of the references provided in the consolidated list were narrative reviews of the health effects of polyphenols in general (rather than specifically of flavanols naturally occurring in cocoa), compositional analysis of food phenolics, and human studies investigating the effects of cocoa polyphenols on health outcomes other than the claimed effect (e.g. insulin sensitivity, blood pressure, endothelial function). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Among the references provided, one systematic review and 11 intervention studies in humans reported on the effects of the food constituent on different markers of oxidative stress or antioxidant status.
A systematic review by Ding et al. (2006) on the effects of cocoa and chocolate on cardiovascular risk factors included nine publications reporting on LDL oxidation, other markers of lipid peroxidation, and/or antioxidant capacity of plasma among the outcomes (Fraga et al., 2005; Kondo et al., 1996; Mathur et al., 2002; Mursu et al., 2004; Osakabe et al., 2001; Serafini et al., 2003; Wan et al., 2001; Wang et al., 2000; Wiswedel et al., 2004). No statistical analysis of the effects of cocoa flavanols on any of the outcomes was provided in the review. All but one (Kondo et al., 1996) of the studies were provided in the references cited for the substantiation of the claimed effect.
Two acute studies (Wang et al., 2000; Wiswedel et al., 2004) and two chronic studies (Mathur et al., 2002; Mursu et al., 2004) reported on F2-isoprostanes, whereas one chronic study reported on in vivo LDL oxidation (Baba et al., 2007b).
Wang et al. (2000) observed no changes in plasma 8-isoprostane concentrations two hours after the ingestion of 27, 53 or 80 g of chocolate (5.3 mg of procyanidin/g of chocolate) in 20 healthy volunteers. Conversely, Wiswedel et al. (2004) observed a significant decrease in plasma concentrations of total F2-isoprostanes 2 and 4 h after the intake of a high-flavanol cocoa drink (187 mg flavan-3-ols/100 mL) versus a low-flavanol cocoa drink (14 mg/100 mL) in ten healthy subjects only when the high-flavanol cocoa drink was consumed after physical exercise.
In a three week clinical trial with parallel design, 45 healthy subjects received 75 g of either dark (365.5 mg catechins/100 g), white (0.3 mg catechins/100 g) or high-polyphenol chocolate (556.8 mg catechins/100 g). No significant differences in changes among study groups were observed with respect to plasma concentrations of F2-isoprostanes (Mursu et al., 2004). Similarly, supplementation of 25 healthy subjects for six weeks (randomised crossover design) with a chocolate bar or a cocoa powder drink (651 mg of flavanols per day) did not affect urinary F2-isoprostanes significantly (Mathur et al., 2002).
In the study by Baba et al. (2007b), 160 subjects were randomised to consume either 13, 19.5 or 26 g/day (corresponding approximately to 140, 190, and 280 mg of flavanols) of cocoa powder as beverage or placebo for four weeks and plasma oxidised LDL concentrations were measured by the ELISA method. In this study the control beverage was adjusted to account for the theobromine content of the cocoa drink. The Panel notes that changes in LDL oxidation during the study between the intervention groups and placebo were not assessed, and therefore no conclusions can be drawn for the scientific substantiation of the claimed effect owing to the uncontrolled nature of the statistical analysis. Dose-response relationships were not reported.
The remaining human intervention studies presented reported on the effects of a single dose of flavanol-containing chocolate/cocoa on the antioxidant capacity of plasma (Serafini et al., 2003 Wang et al., 2000), TBARS (Wang et al., 2000), on the oxidation lag time of LDL ex vivo (Kondo et al., 1996; Hirano et al., 2000), on the effects of daily chocolate/cocoa consumption with different flavanol content (140-651 mg flavanols per day) on oxidation lag time of LDL ex vivo (Osakabe et al., 2001; Wan et al., 2001; Mathur et al., 2002; Mursu et al., 2004; Baba et al., 2007a) or on malondialdehyde (MDA) (Fraga et al., 2005). The Panel considers that these studies, because of the unreliability of the markers used, are not a source of data on their own for the substantiation of the claimed effect (Griffiths et al., 2002; Lykkesfeldt, 2007; Knasmüller et al., 2008).
In weighing the evidence, the Panel took into account that, although one acute study reported significant changes in plasma concentrations of total F2-isoprostanes after a single administration of cocoa flavanols, this effect was not confirmed when cocoa flavanols were consumed daily for 3-6 weeks, and that no effect of cocoa flavanols was observed on plasma concentrations of oxidised LDL particles.
The Panel concludes that a cause and effect relationship has not been established between the consumption of cocoa flavanols and protection of lipids from oxidative damage.

Warunki i możliwe ograniczenia stosowania oświadczenia

At least 168 mg per day (as measured by HPLC)