Effect of a nutraceutical combination on sleep quality among people with mildly impaired sleep: A randomised, placebo-controlled trial

Abstract

Abstract In this randomised, placebo-controlled trial, we assigned adults with a Pittsburgh Sleep Quality Index (PSQI) > = 5 to receive a formulation containing L-theanine (from green tea – Camellia sinensis extract), lemon balm (Melissa officinalis) extract, valerian (Valeriana officinalis) extract, and saffron extract (Crocus sativus), or placebo, during six weeks. We enrolled and randomised 64 individuals, of whom 31 from the active group and 27 from the placebo group completed the six-week follow-up. Mean sleep efficiency remained unmodified in the active group, and increased by 3% in the placebo group, the between-group difference in the change was not statistically significant (p = 0.49). Total sleep time also improved more with placebo (13.0 vs. 1.33 minutes, p = 0.66). Time wake after sleep onset (WASO) decreased more in the active group (4.6% vs. 2.4%), but the difference was not significant (p = 0.33). Mean PSQI decreased by 3.11 points (32.3%) in the active group, and by 3.86 points (39.5%) in the placebo group (p = 0.41). SF-36 increased more with placebo (+ 18.3 in active, + 32.1 in placebo, p = 0.68). Salivary cortisol remained unchanged in both groups. No serious adverse events were reported. Among adults with mildly impaired sleep, a nutraceutical combination did not improve objective or subjective sleep parameters more than a placebo infusion.