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Background <p>Sleep disorders, specifically insomnia, are recognized as global public health concerns. The present study is to evaluate the potential effects of a multi-ingredient formula through a multimodal approach on sleep quality in people with insomnia. The study supplement contained bovine colostrum and egg yolk extracts, ashwagandha root extract, lavender oil, pyridoxal-5-phosphate, melatonin, GABA, and magnesium. Colostrum and egg yolk extracts have been shown to support immune system function and thus likely support sleep health. Ashwagandha root extract, lavender oil, pyridoxal-5-phosphate, melatonin, GABA, and magnesium have been shown to help sleep health and quality via different mechanisms of action.</p> Methods <p>A total of 30 healthy adults with self-reported symptoms of insomnia, divided into placebo and treatment groups, completed a 6-week randomized, double-blinded, placebo-controlled crossover study (1-week washout, 2-week intervention, 1-week washout, and 2-week intervention, sequentially). Participants were instructed to fill out Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ) survey weekly, and keep a sleep diary daily, which were used to assess their sleep quality. Saliva samples were taken from participants before and after each 2-week treatment period to measure salivary melatonin level. Participants were instructed to wear a Fitbit Inspire 2 device to track their sleep and wake data. Linear mixed model ANOVA was used to evaluate statistics for the study.</p> Results <p>Study supplement significantly improved sleep quality of participants compared to placebo group, specifically difficulty falling asleep (<i>p</i> &lt; 0.01). The study supplement also significantly improved the number of awakenings during the night compared to baseline (<i>p</i> &lt; 0.01). Overall sleep health was improved, specifically sleep quality (wakefulness) (<i>p</i> &lt; 0.01). Study supplement also significantly improved salivary melatonin levels compared to placebo group (<i>p</i> &lt; 0.01). Some limitations of the study include a lack of controlled environment and a heterogeneous population, among others.</p> Conclusions <p>The preliminary findings observed in the present study showed that the study supplement improved sleep health and quality for people with insomnia. The importance of finding effective and safe solutions for poor sleep and insomnia cannot be overstated.&#xa0;</p> Study registration <p>ClinicalTrials.gov NCT05368909 “Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality “, registered May 10, 2022. <a href="https://clinicaltrials.gov/study/NCT05368909">https://clinicaltrials.gov/study/NCT05368909</a>.</p>

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Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月10日

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  • Anna Andersen,
  • David Vollmer,
  • Brent Vaughan,
  • Dennis Eggett,
  • Michael A. Grandner,
  • Xuesheng Han

摘要

Background

Sleep disorders, specifically insomnia, are recognized as global public health concerns. The present study is to evaluate the potential effects of a multi-ingredient formula through a multimodal approach on sleep quality in people with insomnia. The study supplement contained bovine colostrum and egg yolk extracts, ashwagandha root extract, lavender oil, pyridoxal-5-phosphate, melatonin, GABA, and magnesium. Colostrum and egg yolk extracts have been shown to support immune system function and thus likely support sleep health. Ashwagandha root extract, lavender oil, pyridoxal-5-phosphate, melatonin, GABA, and magnesium have been shown to help sleep health and quality via different mechanisms of action.

Methods

A total of 30 healthy adults with self-reported symptoms of insomnia, divided into placebo and treatment groups, completed a 6-week randomized, double-blinded, placebo-controlled crossover study (1-week washout, 2-week intervention, 1-week washout, and 2-week intervention, sequentially). Participants were instructed to fill out Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ) survey weekly, and keep a sleep diary daily, which were used to assess their sleep quality. Saliva samples were taken from participants before and after each 2-week treatment period to measure salivary melatonin level. Participants were instructed to wear a Fitbit Inspire 2 device to track their sleep and wake data. Linear mixed model ANOVA was used to evaluate statistics for the study.

Results

Study supplement significantly improved sleep quality of participants compared to placebo group, specifically difficulty falling asleep (p < 0.01). The study supplement also significantly improved the number of awakenings during the night compared to baseline (p < 0.01). Overall sleep health was improved, specifically sleep quality (wakefulness) (p < 0.01). Study supplement also significantly improved salivary melatonin levels compared to placebo group (p < 0.01). Some limitations of the study include a lack of controlled environment and a heterogeneous population, among others.

Conclusions

The preliminary findings observed in the present study showed that the study supplement improved sleep health and quality for people with insomnia. The importance of finding effective and safe solutions for poor sleep and insomnia cannot be overstated. 

Study registration

ClinicalTrials.gov NCT05368909 “Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality “, registered May 10, 2022. https://clinicaltrials.gov/study/NCT05368909.