ABSTRACT
The purpose of this study was to investigate the effects of a novel dietary supplement, including melatonin and magnesium, delivered via coffee pods on sleep quality, resting metabolic rate (RMR), and body composition in individuals with poor sleep quality disturbances. Using a double-blinded, randomized, crossover trial, we recruited 35 participants to a 4-week intervention with both supplements (1.9 mg melatonin + 200 mg elemental magnesium before sleep) and placebo conditions, considering a 7d washout period between treatments. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was applied, RMR (kcal) was measured using indirect calorimetry (canopy ventilated open-circuit system) and body composition was assessed using dual-energy X-ray absorptiometry. Decreases in PSQI and anger – hostility scores, as well as in energy intake and fat mass, were observed (p < 0.05) for both conditions, from baseline to the end of each 4-week intervention. Differences between conditions were also observed for these parameters along with energy spent in activity, number of sedentary breaks, sleep efficiency, latency time, time in bed, total sleep time, awakening time, and movement index (p < 0.05) favouring the supplement condition. However, the final PSQI questionnaire scores still indicated poor sleep quality on average (PSQI > 5), in both conditions, with no changes regarding RMR. A melatonin-magnesium supplement, in a coffee pod format, showed improvements in sleep quality in otherwise healthy individuals with sleep disturbances, however PSQI questionnaire scores still indicated poor quality on average (PSQI > 5).
Acknowledgments
A special thank you to the volunteers for their time and effort.
Author’s contribution
RMC, CNM, FJT- substantial contributions to conception and design; acquisition, analysis and interpretation of data; involved in drafting the manuscript;
MLC, JC, RG, PP, FV – acquisition, analysis and interpretation of data; critically revision of the manuscript for important intellectual content
DAS, JRV, RCLM, SGA, HOS, RJR – Have made substantial contributions to conception and design, and interpretation of data;; critically revision of the manuscript for important intellectual content.
All authors have given final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors agree on the order in which their names are listed in the manuscript.
Disclosure statement
Regarding conflict of interest, all authors declare that the results of the study are presented clearly, honestly, and without fabrication, falsification, or inappropriate data manipulation. FJT, CNM, MLC, RMC and RG are former employees of a biotechnology company (Bettery S.A.) that produces dietary supplements. This company also developed the pods used in this study. All the other authors declare there are no competing interests.
This investigation was approved by the Faculty of Human Kinetics Institutional Review Board (approval 21/2021) and registered at clinicaltrials.gov (NCT05236504), conforming with all standards of human research. All participants gave their verbal and written informed consent before enrolling.
Data availability statement
Data availability is possible partially, for personal use through email contact to the corresponding author.
Correction Statement
This article has been republished with minor changes. These changes do not impact the academic content of the article.