A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial

Catherine Cornu,Pascal Roy,Behrouz Kassaï,Laurent Remontet,Alain Nicolas,Bruno Claustrat,Mitra Saadatian-Elahi,Nathalie Feugier-Favier,Florence Noel-Baron

doi:10.1186/1472-6882-10-29

Abstract

BackgroundTo evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders.MethodsRandomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention consisted of two soft gelatine capsules per day, containing either the dietary supplement (active group) or olive oil (placebo group) for a month. Subjects could also volunteer for two ancillary studies on melatonin and actigraphy. Evaluation criteria included i) perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii) sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii) night melatonin and 6 sulfatoxymelatonin (aMT6S) urine rates in a subsample of subjects.ResultsThe average of Leeds score was similar in both groups (p = 0.95). A marked improvement in the quality of sleep was observed in both placebo (62%) and active (65%) group (p = 0.52). The evolution of urinary melatonin, aMT6S, and of the Mel/aMT6S ratio showed no differences between the two groups. Sleep efficiency, as measured by actigraphy, improved similarly in both groups during the treatment period, from 72% to 76% and 75% in the active and placebo group respectively (p = 0.91).ConclusionsThe dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle.Trial registration: clinical trials.gov:NCT00484497

Highlights

To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders
Our objective was to evaluate the effect of the dietary supplement on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in adult subjects with moderate to severe primary insomnia in a prospective double blind, randomized, placebo-controlled clinical trial
The average of Leeds score was similar in both groups (Likelihood Ratio Test = 0.71, p = 0.95): mean GTS 173.9 and 170.5, QOS 124.8 and 120.1, AFS 161.6 and 159.1, and BFW 118.6 and 118.1 in the placebo group and in the active group respectively (Table 2)

Summary

Introduction

To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders. The estimated incidence of primary insomnia in the general population is 10 to 20% [1,2,3]. The consequences of this disorder are an impaired quality of life, an increase in medical consultations and in hypnotic drug consumption [4]. A hormone produced mostly during the night by the pineal gland, displays the role of an endogenous synchronizer, especially on the sleep-wake cycle [8]. Melatonin receptors are present at the level of the endogenous circadian clock located in the suprachiasmatic nuclei

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