Abstract

This randomized, placebo-controlled, crossover and double-blind study investigates the effects of RLX2™ containing alpha-s1-casein tryptic hydrolysate and L-theanine in working adults affected by poor sleep quality. The supplement or placebo was randomly and blindly assigned to 39 subjects for four weeks and the changes in the subjective sleep assessment via the Pittsburgh Sleep Quality Index (PSQI), heart rate, blood pressure, salivary cortisol by high-performance liquid chromatography method and alpha power of awake electroencephalogram (EEG) were studied. The data were analyzed in two ways, by crossover and crossover summed up. The latter depicted that RLX2™ improved PSQI total score, sleep latency, sleep duration, sleep habitual efficiency, daytime dysfunction, and increased total and frontal alpha power significantly (p < 0.05). The supplement prolonged the total sleeping time by 45 min in the supplement receiving group compared to the placebo group (p < 0.001). However, only sleep duration and sleep habitual efficiency showed a profound effect in both analyses (p < 0.05). In conclusion, being given its beneficial effects without notable adverse events, it would be advantageous to use these nutraceutical ingredients to promote better sleep quality. Further studies with a larger number participants are warranted to support these findings.

Highlights

  • Healthcare professionals have stressed the importance of assessing sleep quality in addition to sleep quantity

  • The placebo receiving group in Stage 1 showed a significant decrease in the Pittsburgh Sleep Quality Index (PSQI) total score by 1.38 (p = 0.026), this is likely caused by a placebo effect

  • Given that hyperarousal may be exacerbated by many factors such as work or financial stress, the aim of this study was to investigate whether four weeks of oral daily intake of the supplement would improve various sleep factors in Malaysians suffering from poor sleep quality

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Summary

Introduction

Healthcare professionals have stressed the importance of assessing sleep quality in addition to sleep quantity. Sleep quality is better related to sleepiness, health, and wellbeing than sleep quantity in a non-clinical population [1]. Poor sleep quality is a defining criterion of insomnia [2,3], and this sleep disorder may interfere with normal physical, mental and emotional functioning, yet affected people are often not aware of their problem and may not be getting appropriate treatment. Few studies have been carried out to explore the epidemiological nature of sleep problems, insomnia, among Malaysian populations. It was stated that for those 50 years old above, anxiety and depression were risk factors for chronic insomnia with daytime dysfunction [4]. Insomnia may lead to anxiety and stress and vice versa which can be a risk factor for psychotic disorder. People with persistent sleep disturbances are more prone to accidents, have higher rates of work absenteeism, diminished job performance, decreased quality of life, and increased health care utilization [5]

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