Trial reportBMC complementary and alternative medicine2010
A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial.
Trial report in BMC complementary and alternative medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00484497 (A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Dietary Supplement Interventions and Sleep Quality Improvement: A Systematic Review and Meta-Analysis.Nutrients · 2025Pooled it
- Omega-3 long-chain polyunsaturated fatty acid and sleep: a systematic review and meta-analysis of randomized controlled trials and longitudinal studies.Nutrition reviews · 2021Pooled it
- Fatty acids and sleep in UK children: subjective and pilot objective sleep results from the DOLAB study--a randomized controlled trial.Journal of sleep research · 2014Trial
- Trial
- Effects of PeptiSleep™ on sleep modification and biometrics in adults with sleep impairment: A randomised, placebo-controlled pilot study.Sleep medicine: X · 2026Article
- International Society of Sports Nutrition Position Stand: Long-Chain Omega-3 Polyunsaturated Fatty Acids.Journal of the International Society of Sports Nutrition · 2025Review
- Association Between ω-3, ω-6 Polyunsaturated Fatty Acid and Sleep Disorders: From Cross-Sectional to Mendelian Randomization Studies.Food science & nutrition · 2025Article
- Intranasal dexmedetomidine improves postoperative sleep quality in older patients with chronic insomnia: a randomized double-blind controlled trial.Frontiers in pharmacology · 2023Article
- The relationship between dietary total antioxidant capacity, clinical parameters, and oxidative stress in fibromyalgia syndrome: A novel point of view.Turkish journal of physical medicine and rehabilitation · 2022Article
- Associations of Dietary ω-3, ω-6 Fatty Acids Consumption with Sleep Disorders and Sleep Duration among Adults.Nutrients · 2021Article
- Use of Plant-Derived Natural Products in Sleep Disturbances.Advances in experimental medicine and biology · 2021Review
- Cinnamon and Hop Extracts as Potential Immunomodulators for Severe COVID-19 Cases.Frontiers in plant science · 2021Article
- Effects of sleep-inducing juice on sleep quality and heart rate variability in adults with disturbed sleep.Nutrition research and practice · 2020Article
- A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Evaluating the Evidence Base of Melatonin, Light Exposure, Exercise, and Complementary and Alternative Medicine for Patients with Insomnia Disorder.Journal of clinical medicine · 2020Review
- Plant Extracts for Sleep Disturbances: A Systematic Review.Evidence-based complementary and alternative medicine : eCAM · 2020Review
- Overexpression ofFrontiers in plant science · 2020Article
- Dietary factors and fluctuating levels of melatonin.Food & nutrition research · 2012Article
- Associations Between Dietary Patterns and Sleep-Related Impairment in a Cohort of Community Physicians: A Cross-sectional Study.American journal of lifestyle medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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 registrationclinical trials.gov:NCT00484497.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.