Scientific Opinion on the substantiation of health claims related to
melatonin and alleviation of subjective feelings of jet lag (ID 1953), and
reduction of sleep onset latency, and improvement of sleep quality (ID
1953) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Melatonin
health claims
jet lag
sleep onset latency
sleep quality
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is melatonin, which is a hormone produced by the pineal gland during the hours of darkness. Melatonin can be measured by established methods.
The Panel considers that the food constituent, melatonin, which is the subject of the health claim is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zmniejszenie subiektywnych odczuć związanych ze zmianą strefy czasowej (jet lag) (ID 1953)
The claimed effect is "sleep-wake cycle regulation”. The Panel assumes that the target population is the general population.
“Sleep-wake cycle regulation” is not sufficiently defined. In the context of the proposed wordings, the Panel assumes that “sleep-wake cycle regulation” encompasses subjective feelings of jet lag.
The Panel considers that alleviation of subjective feelings of jet lag might be a beneficial physiological effect.
2.2. Zmniejszenie trudności w zasypianiu i poprawa jakości snu (ID 1953)
The claimed effect is "sleep-wake cycle regulation”. The Panel assumes that the target population is the general population. “Sleep-wake cycle regulation” is not sufficiently defined. In the context of the proposed wordings, the Panel assumes that “sleep-wake cycle regulation” encompasses helping to reduce sleep onset latency and helping to improve sleep quality.
The Panel considers that reduction of sleep onset latency or improvement of sleep quality might be beneficial physiological effects.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
The references cited to substantiate the claim included a total of 17 publications. Seven were reviews, including a Cochrane Systematic Review, and one was a comparison of circadian characteristics between healthy elderly people and young adults. The Panel notes that, of these seven references, only the Cochrane Systematic Review (Herxheimer and Petrie, 2002, reviewed 2008) is suitable for substantiating the claimed effect. The remaining 11 references reported on intervention studies with melatonin. Four of these intervention studies (Dahlitz et al., 1991; Nagtegaal et al., 1998; Kayumov et al., 2001; Mundey et al., 2005) were undertaken in patients who were diagnosed with delayed sleep phase syndrome, one (Haimov and Lavie, 1997) was undertaken in melatonin deficient elderly people, one (Siegrist et al., 2001) in sleep-disturbed middle-aged and elderly patients, most of whom were also on benzodiazepine treatments and one (Kunz et al., 2004) reported on two trials in patients with unselected neuropsychiatric sleep disorders and reduced rapid-eye-movement (REM) sleep duration. The Panel considers that the evidence provided does not establish that patients with various forms of sleep disorders, such as primary or secondary sleep disorders, are representative of the general population or that results obtained in studies on subjects with various forms of sleep disorders relating to the treatment of symptoms of this condition can be extrapolated to the general population.
The Panel, however, considers that results obtained from sleep disorders accompanying sleep restriction as a result of lifestyle and work schedules, such as air travel and shift work, can be extrapolated to the general population.
3.1. Zmniejszenie subiektywnych odczuć związanych ze zmianą strefy czasowej (jet lag) (ID 1953)
Three (Petrie et al., 1989; Petrie et al., 1993; Arendt and Marks, 1986) of the remaining four references, which were provided, reported on the chronobiotic effects of melatonin with respect to subjective feelings of jet lag in healthy adults after long-haul flights, as did the aforementioned Cochrane Systematic Review. The study of Pierard et al. (2001) investigated outcomes on hormonal rhythms.
The Cochrane Systematic Review (Herxheimer and Petrie, 2002, reviewed 2008) of randomised placebo-controlled trials with melatonin interventions for alleviating jet lag, which included the aforementioned two Petrie studies and the Arendt study along with eight other studies not included in the 17 references provided by Member States and stakeholders, had as primary measure subjective ratings of jet lag. The conclusions of this review were that melatonin (0.5 to 5 mg/day) is effective in preventing or reducing jet lag. The Panel considers that these findings indicate a role for melatonin in decreasing subjective ratings of jet lag scores.
In weighing the evidence, the Panel took into consideration the conclusions of the Cochrane review, which indicated that melatonin was effective in alleviating the subjective symptoms of jet lag.
The Panel concludes that a cause and effect relationship has been established between the consumption of melatonin and alleviation of subjective feelings of jet lag.
3.2. Zmniejszenie trudności w zasypianiu i poprawa jakości snu (ID 1953)
No data were provided on the effects of melatonin on sleep onset latency or on sleep quality. The Panel, however, notes that a meta-analysis (Buscemi et al., 2006; not provided by the Member States or stakeholders) on the efficacy of melatonin for secondary sleep disorders accompanying sleep restriction concluded that there is no evidence that melatonin is effective in treating sleep onset latency (data from nine studies with 508 participants) or measures of sleep quality (data from five studies with 386 participants) in people with sleep disorders accompanying sleep restriction, such as jet lag and shift-work disorder. Only one of the trials (Suhner et al., 1998) included in the Cochrane Review was common to the meta-analysis on the efficacy of trials with melatonin on people with sleep disorders accompanying sleep restriction and the Panel also notes that the meta-analysis did not examine the effect of melatonin on subjective feelings of daytime fatigue and the sleep disturbance aspects of jet lag.
In weighing the evidence, the Panel accepted the conclusions of the meta-analysis with respect to the outcomes of sleep onset latency and sleep quality.
The Panel concludes that a cause and effect relationship has not been established between the consumption of melatonin and reduction of sleep onset latency or improvement of sleep quality.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Zmniejszenie subiektywnych odczuć związanych ze zmianą strefy czasowej (jet lag) (ID 1953)
The Panel considers that the following wording reflects the scientific evidence: “Melatonin contributes to the alleviation of subjective feelings of jet lag.”.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
5.1. Zmniejszenie subiektywnych odczuć związanych ze zmianą strefy czasowej (jet lag) (ID 1953)
The Panel considers that in order to bear the claim, the melatonin dose should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and any subsequent day) of travel and on the following few days after arrival at the destination. The target population is the general population. Melatonin appears to be safe with short-term use (three months or less). There are no data on safety for children and older people.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, melatonin, that is the subject of the health claim is sufficiently characterised.
Alleviation of subjective feelings of jet lag (ID 1953)
The claimed effect is "sleep-wake cycle regulation”. The target population is assumed to be the general population. Alleviation of subjective feelings of jet lag might be a beneficial physiological effect.
A cause and effect relationship has been established between the consumption of melatonin and alleviation of subjective feelings of jet lag.
The following wording reflects the scientific evidence: “Melatonin contributes to the alleviation of subjective feelings of jet lag”.
In order to bear the claim, the melatonin dose should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and any subsequent day) of travel and on the following few days after arrival at the destination. The target population is the general population.
Reduction of sleep onset latency and improvement of sleep quality (ID 1953)
The claimed effect is "sleep-wake cycle regulation”. The target population is assumed to be the general population. Reduction of sleep onset latency and improvement of sleep quality might be beneficial physiological effects.
A cause and effect relationship has not been established between the consumption of melatonin reduction of sleep onset latency or improvement of sleep quality.