Summary: Ritual announced the completion of a clinical trial on its Sleep BioSeries melatonin, a time-release supplement designed to support sleep by maintaining sustained melatonin levels throughout the night. The study, which utilized a randomized, double-blind, placebo-controlled, crossover design, demonstrated that the supplement promoted quicker onset of sleep and sustained melatonin levels until morning, compared to a placebo.
Key Takeaways:
- Sustained Melatonin Levels: The clinical study confirmed that Sleep BioSeries melatonin maintains elevated melatonin levels in the blood throughout the night, tapering off by the six-hour mark, which supports the body’s natural sleep-wake cycle.
- Improved Sleep Onset and Quality: Participants in the study experienced a 43% reduction in the time it took to fall asleep and reported better deep sleep patterns.
- No Rebound Effects: The trial also found that users of Sleep BioSeries melatonin woke up feeling refreshed without experiencing any rebound effects.
Health and wellness brand Ritual announced the completion of a clinical trial on its Sleep BioSeries melatonin, a time-release sleep support supplement, which was shown to support the natural cycle of sleep-wake patterns. The three-in-one tablet in capsule technology combines 5 mg of instant- and extended-release melatonin.
Sleep BioSeries melatonin was clinically shown to reach peak melatonin levels faster than placebo and promote sustained melatonin levels in the blood throughout the night before tapering off at the six-hour mark toward morning.
“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 provide sustained support but may lack the immediate effect needed to fall asleep,” says Mastaneh Sharafi, PhD, senior vice president of science and innovation at Ritual, in a release. “We formulated Sleep BioSeries with our innovative BioSeries technology to provide both immediate and sustained support to promote better sleep patterns.”
Assessing Sleep BioSeries Melatonin
The randomized, double-blind, placebo-controlled, crossover design was used to assess the pharmacokinetics (N=10) and two-week supplementation (N=12) effects of Sleep BioSeries melatonin. Participants were adults ranging in age from 18 to 31 with reported sleep difficulty.
Findings show:
- With 1 mg of instant-release melatonin in the first tablet to support falling asleep, Sleep BioSeries melatonin is clinically shown to reduce time to fall asleep by 43%.
- With 3 mg of extended-release melatonin in the second tablet to support restful sleep, Sleep BioSeries melatonin is clinically proven to support better deep sleep patterns.
- With 1 mg of extended melatonin in the third tablet that tapers off by the morning, Sleep BioSeries Melatonin is clinically shown to help wake up fresh and rested with no rebound effects.
“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,” says Katerina Schneider, founder and CEO of Ritual, in a release. “All our products are formulated with ingredients backed by the latest science, but this gives our customers extra validation that the ingredients are actually working.”
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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