Effects of PeptiSleep™ on sleep modification and biometrics in adults with sleep impairment: A randomised, placebo-controlled pilot study

Sleep is vital for longevity and daily function but is under threat due to modern culture. While pharmaceuticals induce and prolong sleep, dependency and side effects can be significant. Artificial intelligence and peptide science have accelerated the accurate identification of natural, bioavailable compounds in a way previously limited to pharmaceutical discovery. This randomised, placebo-controlled, parallel pilot study investigated the effects of a rice protein hydrolysate, PeptiSleep™, on sleep quality in 26 adults (18-65 years old) with sleep impairment over 56 days. This small, single-blinded study was designed as exploratory; findings should be interpreted accordingly, with no adjustments made for multiple comparisons on secondary endpoints. PeptiSleep™ group scores were higher than the placebo in all sub-categories of the Leeds Sleep Evaluation Questionnaire, with nominally significant changes in Getting To Sleep (p = 0.050) and Quality Of Sleep (p = 0.036) domains. The Profile of Mood States indicated a nominally significant difference (p = 0.050) in total mood disturbance alongside non-significant differences in sleep diaries and questionnaires related to stress, anxiety, sleepiness, and insomnia. Exploratory analysis of objective biometrics, tracked passively using Oura wearable technology suggested potential differences in heart rate variability, sleep architecture, and latency between groups. PeptiSleep™ is the first in silico predicted ingredient to be assessed for sleep quality in a placebo-controlled trial.