Abstract
We previously reported that rice bran extract supplement (RBS) administration to mice decreased sleep latency and induced non-rapid eye movement (NREM) sleep via inhibition of the histamine H1 receptor. Based on this, we performed the first clinical trial to investigate whether RBS would be beneficial to subjects with disturbed sleep. We performed a randomized, double‐blinded, placebo‐controlled, 2-week study. Fifty subjects with sleep disturbance were enrolled and received either RBS (1,000 mg/day) or placebo. Polysomnography was performed, and Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale (ESS), and Fatigue Severity Scale were administered at the initiation and termination of the study. Compared with the placebo, RBS led to significant polysomnographic changes, including decreased sleep latency (adjusted, P = 0.047), increased total sleep time (P = 0.019), and improved sleep efficiency (P = 0.010). Additionally, the amount of stage 2 sleep significantly increased in the RBS group. When adjusted for caffeine intake, wakefulness after sleep onset, total wake time, and delta activity tended to decrease in the RBS group. RBS administration decreased ESS scores. There were no reported serious adverse events in both groups. RBS improved sleep in adults with sleep disturbance. Trial registration: WHO ICTRP, KCT0001893.
Highlights
Insomnia is the most common sleep-related complaint, and approximately 10–40% of adults experience insomnia at some point during their lifetime[1,2,3]
There were no significant differences between the placebo and rice bran extract supplement (RBS) groups in terms of age, sex, body mass Index (BMI), and blood pressure
In our previous study, rice bran constituents such as β‐sitosterol, campesterol, stigmasterol, (±)‐α‐tocopherol, and ferulic acid affected sleep in a pentobarbital‐induced sleep test compared with doxepin hydrochloride as a positive control[8]
Summary
Insomnia is the most common sleep-related complaint, and approximately 10–40% of adults experience insomnia at some point during their lifetime[1,2,3]. We recently reported that similar to doxepin used in the treatment of insomnia, rice bran extract supplement (RBS) potentiated pentobarbital-induced sleep in mice[12]. R-oryzanol, β‐sitosterol, campesterol, stigmasterol, ferulic acid, and (±)‐α‐tocopherol, which are rice bran constituents, increased the sleeping time in ICR mice with pentobarbital-induced sleep[14]. These results suggest that the RBS may be a promising agent for the improving sleep this results are mainly from animal model. We designed the first RBS randomized, double-blind, placebo-controlled trial employing overnight polysomnography (PSG) recordings as well as sleep-related standardized scales
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