Abstract
Objectives: This study assessed the effects of oral porcine placental extract (PPE) on sleep quality of healthy volunteers not satisfied with their sleep.Design: This study used a randomized, placebo-controlled, double-blind, cross-over clinical pilot study.Setting: This study was conducted under an outpatient multicenter setting in Japan.Interventions: A total of 20 healthy Japanese volunteers aged between 28 and 73, whose Pittsburgh Sleep Quality Index global scores were between 6 and 10, successfully completed the study. At first, PPE at 300 mg/kg or placebo was ingested for 2 weeks. Then, after a 2-week washout period, each group ingested under a cross-over setting the opposite sample (placebo or PPE) for another 2 weeks.Main Outcome Measures: Objective measurement of the sleep made with an activity tracker and subjective measurements of sleep quality by use of St. Mary's Hospital Sleep Questionnaire were done just before and after the administration time slots.Results: No effect of PPE on the sleep length was observed. Several measures in the subjective St. Mary's Hospital Sleep Questionnaire, i.e., changes in Q5 (sleep depth) and Q9 (sleep wellness) between pre- and post-ingestions, were significantly different between groups in the direction of improvement of subjective sleep quality in the PPE group.Conclusions: Although oral PPE at 300 mg/day for 2 weeks did not affect the length of sleep itself, it significantly improved several measures of subjective sleep quality. These results suggest that PPE might be a way to improve sleep quality without hypnotic drugs.Clinical Trial Registration: www.umin.ac.jp/ctr/, identifier: UMIN000026468.
Highlights
Getting sufficient sleep is crucial for a healthy life of all people
We focused on porcine placental extract (PPE) as the food material having the potential to improve sleep
The data on sleep length taken from the activity tracker are depicted in Table 2, where in addition to total sleep length, lengths of deep and light sleep periods are shown
Summary
Getting sufficient sleep is crucial for a healthy life of all people. In the modern world, insufficient sleep has become recognized as the cause of a variety of health problems. Sleep deprivation causes excess daytime sleepiness and trouble in concentration, resulting in lower performance of tasks (1) as well as accidents (2, 3). Insufficient sleep affects the autonomic activity (4) which possibly leads to depression (5), diabetes (6), hypertension (7), atherosclerosis (7), and so on. Improvement of sleep is important to prevent such a variety of health troubles. Because hypnotic drugs have inherent risks of side effects, other ways to improve sleep are needed
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