With a cutting-edge, two-phase clinical approach, the study showcases Nella's broader health benefits along with its potential to transform the way we approach sleep and probiotic alternatives to sleep aids.
The research, which initially observed improvements in sleep quality in a diverse group of individuals, has now been validated through a rigorous placebo-controlled study involving the following:
The study, split into two parts, evaluated the effects of a FitBiomics proprietary multi-strain Lactobacillus probiotic on safety as well as a comprehensive list of health outcomes.
The first part of the study involved 257 participants from the general public (average age 40.9 years old) who took 1 capsule of probiotic (either a high or low dose) daily for 2 weeks. 94% of whom reported notable health improvements after taking the probiotic daily for 2 weeks.
The second part of the study, a placebo-controlled trial, involved professional soccer players. Significant improvements in sleep quality (69%), energy levels (31%), and bowel regularity (37%) were observed in the probiotic group compared to the placebo group.
The open label study identified benefits in sleep and energy, while the controlled longitudinal study validated the open label study results.
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"Our study indicates that probiotics have the potential to transform how we approach sleep quality. This probiotic consortium offers a safe, reliable, and more natural route to improved sleep quality, without the associated risks that have become a concern with popular sleep supplements.”
— Alex Kostic, the study’s corresponding author, FitBiomic Co-Founder and Asst. Professor of Microbiology at Harvard Medical School
Unlike traditional sleep aids such as melatonin, which has seen a worrying rise in pediatric overdoses and variable supplement quality, this probiotic consortium exhibited no serious or unexpected adverse events. This new data, therefore, provides a safer and potentially more consistent alternative, drastically reducing potential health risks associated with over-the-counter sleep aids.
Amid a surge in diagnosed sleep disorders, especially during the pandemic, and rising melatonin usage, the need for safer and more effective sleep aids has never been more pressing. Pediatric emergency medicine has observed a significant rise in children overdosing on melatonin with an alarming increase in calls to poison control. This issue, coupled with the inconsistent amounts of melatonin in various supplement brands, calls into question the safety and reliability of melatonin as a sleep aid.
This study marks an important milestone in our understanding of the role probiotics play in improving sleep quality and overall health. As the global population increasingly turns to probiotics for a range of health benefits, these findings pave the way for advanced probiotic interventions that can revolutionize wellness.
“What better time than World Microbiome Day to recognize fresh insights into the molecular mechanisms driving these health benefits,” says Jonathan Scheiman, PhD, CEO and co-founder of Fitbiomics. “This research highlights the specific changes in gut microbiome composition and function that contribute to Nella's effectiveness and also underscores our ability to translate microbiome research into real-world health solutions that have the potential to benefit broad populations.”
The team behind this research has a history of notable discoveries, including previous work published in prestigious journals such as Nature Medicine and featured in respected media outlets like The New York Times, Scientific American, and NPR's Science Friday. Their ongoing efforts continue to shed light on the intricate and vital role the gut microbiome plays in human health and performance.