Title : Effects of a combination of tryptophan, magnesium, lactuca and melissaon sleep quality and daytime performance in healthy adults with disturbed sleep: A prospective pilot study
Abstract:
Introduction: Insufficient sleep is a major problem in modern society. Current pharmaceutical options for sleep disorders often have significant side effects such as dependency or drowsiness on the next day (Morin et al. 2012). Thus, the need for alternative self-therapy options is on the rise. This pilot study aimed to investigate the effects of a formulation containing plant extracts from fresh Lactuca sativa and Melissa officinalis combined with Tryptophan and Magnesium, in adults with self-reported disturbed sleep.
Materials and Methods: This was a single-armed open-label prospective pilot study conducted monocentric in Germany. After a 3 day run in phase, N=50 subjects were instructed to take the formulation as direct granulate in sachets once a day 0.5-1 h prior going to bed for 14 days (chronic use). Qualitative and quantitative effects on sleep, daytime performance, well-being and safety were assessed by a daily online diary, questionnaires, computerized cognition tests and exploratory measures by wearables and saliva samples. A small subset of N=10 additionally performed objective sleep measurements by an ambulatory polysomnography (PSG). In addition to this chronic use, an acute intake was performed during two on-site visits to assess acute effects on anxiety and cognitive performance (acute dose).
Results and Discussion: There was a significant improvement of 14% in perceived sleep quality (SF-B/R Sleep Quality Index, primary parameter) relative to baseline (p<0.001) following chronic use. A differentiated analysis indicated that in particular exceptionally anxious subjects profited significantly more from improvements in sleep quality measures. Perceived sleep enjoyment on weekdays increased by 25% (p<0.001) and reached similarly positive levels as on weekends. Subjective difficulty of falling asleep and well-being before sleep improved likewise by 4%, resp. 6% (p≤0.020). Difficulty of sleeping-through the night and problems with waking-up before time significantly reduced by 9%, resp. 16% (p≤0.003). The number of nightly awakenings reduced by 23% (p<0.001). Exploratory assessments of sleep quantity (duration, onset time and wake time) by wearables and PSG as well as bioanalysis of saliva samples did not provide confirmatory effects. Relevant positive effects on slow wave sleep duration prolongation (+28%) were still observed with PSG (p>0.05). Similarly, psychological well-being and daytime performance improved significantly and highly consistently. While daytime sleepiness reduced by 13% (p= 0.006) and mood increased by 23% (assessed via a depression scale, p<0.014) after 2 weeks , feeling of restedness increased by +21% after 1 week and 31% after 2 weeks (p<0.001). Symptoms of psychological tension reduced by 23% after 1 week and by 28% after 2 weeks (p<0.001). Anxiety and stress symptoms also reduced by 25%, resp. 18%, driven by similar effect sizes after acute use (p≤0.02). Objectively assessed executive function task performance significantly and consistently improved following acute dose by 7% resp. chronic use by 13% (p<0.001) and thus, further corroborate positive effects on daytime performance. The administration of the formulation was associated with high compliance (102 ± 12 %). No serious adverse events were reported.
Conclusions: This study provides first evidence that the combination of the medicinal plants fresh Lactuca sativa and Melissa officinalis with Tryptophan and Magnesium may be beneficial in disturbed sleep and may further contribute to daytime mental performance and psychic well-being.
