Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study
Abstract 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 bov...
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BMC
2025-02-01
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| Series: | Sleep Science and Practice |
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| Online Access: | https://doi.org/10.1186/s41606-024-00122-7 |
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| author | Anna Andersen David Vollmer Brent Vaughan Dennis Eggett Michael A. Grandner Xuesheng Han |
| author_facet | Anna Andersen David Vollmer Brent Vaughan Dennis Eggett Michael A. Grandner Xuesheng Han |
| author_sort | Anna Andersen |
| collection | DOAJ |
| description | Abstract 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 . |
| format | Article |
| id | doaj-art-9de857a17fb6404fb46b77d6a45245ac |
| institution | DOAJ |
| issn | 2398-2683 |
| language | English |
| publishDate | 2025-02-01 |
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| series | Sleep Science and Practice |
| spelling | doaj-art-9de857a17fb6404fb46b77d6a45245ac2025-08-20T02:48:18ZengBMCSleep Science and Practice2398-26832025-02-019111210.1186/s41606-024-00122-7Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical studyAnna Andersen0David Vollmer1Brent Vaughan2Dennis Eggett3Michael A. Grandner4Xuesheng Han54Life Research LLC4Life Research LLC4Life Research LLCStatistics Department, Brigham Young UniversityUniversity of Arizona College of Medicine4Life Research LLCAbstract 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 .https://doi.org/10.1186/s41606-024-00122-7Bovine colostrumInsomniaSleepSleep qualitySleep healthMelatonin |
| spellingShingle | Anna Andersen David Vollmer Brent Vaughan Dennis Eggett Michael A. Grandner Xuesheng Han Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study Sleep Science and Practice Bovine colostrum Insomnia Sleep Sleep quality Sleep health Melatonin |
| title | Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study |
| title_full | Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study |
| title_fullStr | Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study |
| title_full_unstemmed | Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study |
| title_short | Assessment of a multi-ingredient dietary supplement on sleep quality: a randomized, double-blinded, placebo-controlled crossover clinical study |
| title_sort | assessment of a multi ingredient dietary supplement on sleep quality a randomized double blinded placebo controlled crossover clinical study |
| topic | Bovine colostrum Insomnia Sleep Sleep quality Sleep health Melatonin |
| url | https://doi.org/10.1186/s41606-024-00122-7 |
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