08.26.24
A recent clinical study found that supplement brand Ritual’s Sleep BioSeries Melatonin provided optimal melatonin delivery throughout a night of sleep to support sleep-wake patterns.
"Melatonin products on the market are mostly either instant-release, which can help you fall asleep quickly but may wear off soon, or slow/extended-release, which provides sustained support but may lack the immediate effect needed to fall asleep," said Mastaneh Sharafi PhD, RD, senior vice president of science and innovation at Ritual. "We formulated Sleep BioSeries with our innovative BioSeries technology to provide both immediate and sustained support, to promote better sleep patterns. We're proud to have demonstrated the efficacy of this technology in a pharmacokinetic and 2-week supplementation clinical trial."
The study, which hasn’t been published, was designed to assess both pharmacokinetics of the supplement, and the effects of two weeks of supplementation, according to the company. The study was a randomized, double-blind, placebo-controlled pharmacokinetic crossover study among 12 adults between the ages of 18 and 31 who reported sleep difficulty.
According to the study, the one-gram instant release of melatonin in the first tablet of the series released within the first hour, and Sleep BioSeries Melatonin reduced the average reported time to fall asleep by 43%.
Three milligrams of extended-release melatonin promoted a peak plasma melatonin concentration at 2.5 hours, which was evidenced to promote a more deeper, restful sleep in the study.
The final 1 mg dose of extended melatonin in the third tablet began to taper off at six hours post-administration on average, according to the findings. "Ritual's Sleep BioSeries Melatonin optimized melatonin delivery through a night of sleep to support the sleep-wake cycle" compared to placebo in the study, the company noted.
“This clinical trial is another important milestone in our commitment to completing clinical trials on all Ritual products by 2030 in partnership with leading universities and research organizations,” said Katerina Schneider, founder and CEO of Ritual. “All of our products are formulated with ingredients backed by the latest science, but this gives our customers extra validation that the ingredients are actually working.”
Previously, the brand completed a university-led clinical trial on its Essential for Women Multivitamin 18+, published in Frontiers in Nutrition, and a clinical trial on its HyaCera wrinkle support formula. The randomized, double-blind, placebo-controlled study on HyaCera was conducted on 63 women and men between the ages of 26 and 64 years old.
The brand also completed two in vitro studies on its Synbiotic+ supplement, and uses clinically studied ingredients with strategic doses and forms across the rest of its product line.
Ritual noted in the announcement of the study results that the statements it made have not been evaluated by the Food and Drug Administration, and Sleep BioSeries Melatonin is not intended to diagnose, treat, cure, or prevent any disease.
"Melatonin products on the market are mostly either instant-release, which can help you fall asleep quickly but may wear off soon, or slow/extended-release, which provides sustained support but may lack the immediate effect needed to fall asleep," said Mastaneh Sharafi PhD, RD, senior vice president of science and innovation at Ritual. "We formulated Sleep BioSeries with our innovative BioSeries technology to provide both immediate and sustained support, to promote better sleep patterns. We're proud to have demonstrated the efficacy of this technology in a pharmacokinetic and 2-week supplementation clinical trial."
The study, which hasn’t been published, was designed to assess both pharmacokinetics of the supplement, and the effects of two weeks of supplementation, according to the company. The study was a randomized, double-blind, placebo-controlled pharmacokinetic crossover study among 12 adults between the ages of 18 and 31 who reported sleep difficulty.
According to the study, the one-gram instant release of melatonin in the first tablet of the series released within the first hour, and Sleep BioSeries Melatonin reduced the average reported time to fall asleep by 43%.
Three milligrams of extended-release melatonin promoted a peak plasma melatonin concentration at 2.5 hours, which was evidenced to promote a more deeper, restful sleep in the study.
The final 1 mg dose of extended melatonin in the third tablet began to taper off at six hours post-administration on average, according to the findings. "Ritual's Sleep BioSeries Melatonin optimized melatonin delivery through a night of sleep to support the sleep-wake cycle" compared to placebo in the study, the company noted.
“This clinical trial is another important milestone in our commitment to completing clinical trials on all Ritual products by 2030 in partnership with leading universities and research organizations,” said Katerina Schneider, founder and CEO of Ritual. “All of our products are formulated with ingredients backed by the latest science, but this gives our customers extra validation that the ingredients are actually working.”
Previously, the brand completed a university-led clinical trial on its Essential for Women Multivitamin 18+, published in Frontiers in Nutrition, and a clinical trial on its HyaCera wrinkle support formula. The randomized, double-blind, placebo-controlled study on HyaCera was conducted on 63 women and men between the ages of 26 and 64 years old.
The brand also completed two in vitro studies on its Synbiotic+ supplement, and uses clinically studied ingredients with strategic doses and forms across the rest of its product line.
Ritual noted in the announcement of the study results that the statements it made have not been evaluated by the Food and Drug Administration, and Sleep BioSeries Melatonin is not intended to diagnose, treat, cure, or prevent any disease.
