Dark coffee consumption protects human blood cells from spontaneous DNA damage

GlycoLite™ and helps to reduce body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

“…Indeed, none of the studies provided by the applicant unequivocally demonstrates that the proposed changes in cytosolic and nuclear concentrations of Nrf2, the expression and activity of ARE/EpRE‐dependent enzymes, or any other cellular cascade triggered by coffee constituents, directly affects DNA strand breaks in humans and as such improves DNA integrity. In particular, the only human intervention study that investigated DNA strand breaks and Nrf2 translocation, which was provided by the applicant and is described above (Pahlke et al., ), did not allow conclusions to be drawn on the link between Nrf2 translocation and DNA strand breaks, owing to the methodological limitations of this study. The other human studies that were provided by the applicant (Boettler et al., 2011a; Volz et al., ), compared in one‐arm sequential trials Nrf2‐gene transcription levels in periods in which subjects refrained from coffee consumption and restricted the amounts of polyphenols in the diet with periods of coffee consumption, but did not investigate DNA strand breaks.…”

“…Seven publications reporting on six human intervention studies were identified by the applicant as pertinent to the health claim (Misik et al., ; Bakuradze et al., ; Richling et al., unpublished study report, ; Shaposhnikov et al., ; Hochkogler et al., ; Pahlke et al., ; Schipp et al., ;). Two publications (Hochkogler et al., ; Pahlke et al., ) report on the same study.…”

“…Four placebo‐controlled, randomised, single‐blind, parallel studies (Bakuradze et al., ; Richling et al., ; Pahlke et al., ; Schipp et al., ) investigated the effect of Coffee C21 on DNA strand breaks using a similar design. The sample populations of the studies were healthy, non‐smoking, habitual coffee drinkers accustomed to the required amount of coffee to be consumed during the study, comprising both males and females, except for the study by Bakuradze et al.…”

“…Pahlke et al. () randomised subjects after the run‐in period (stratified by gender and BMI by using a computer‐generated randomisation list) into two groups. The intervention group consumed 750 mL/day Coffee C21 without milk in three equal portions per day for 8 weeks; the control group drank equal volumes of warm water.…”

“…In relation to the indirect pathway, the applicant cited the following studies that were conducted either with coffee as such or single coffee constituents: 3 human studies (Boettler et al., 2011a; Volz et al., ; Pahlke et al., ), 6 animal studies (Cavin et al., ; Paur et al., ; Balstad et al., ; Salomone et al., ; Vicente et al., ; Shi et al., ) and 11 in vitro studies (Bakuradze et al., ; Kalthoff et al., ; Paur et al., ; Boettler et al., ,b; Volz et al., ; Sauer et al., ; Fratantonio et al., ; Jung et al., ; Priftis et al., ; Shen et al., ).…”