Data from a double-blind, randomized crossover trial with 48 participants indicated that four weeks of supplementation with 300 mg per day of Lactium resulted in “sleep efficiency”, a measure of the spent asleep while in bed as measured by both subjective (sleep diary) and objective (actigraphy) methods.
In addition, data from sleep diaries also indicated that the participants reported improvements in total sleep time after Lactium supplementation.
“Interestingly, the effects of [Lactium] on [sleep efficiency] were more obviously demonstrated after four weeks of consumption compared to two weeks, which suggests that [Lactium] can improve sleep quality when administered for an extended period without substantial side effects or tolerance issues,” wrote the authors in Nutrients.
“This finding can be a significant advantage of dietary supplements relative to other conventional hypnotic medications, which often show reduced effects or tolerance after long-term use.”
Sleep – a growing category
Sleep is top of mind for many consumers, with data from the Datamonitor Consumer 2014 survey indicating that “insomnia” was tied for the fourth most prominent health issue of American consumers ranked by percentage, coming in behind stress, tiredness and fatigue (which itself is related to sleep), and allergy. The most worried demographic when it comes to insomnia was middle-age women.
This has led to a rapid growth in the sleep aid category in the US, which is reported to be growing at almost 30% year-on-year and predicted to hit $732 million in 2018, according to Euromonitor International.
The category is dominated by P&G’s ZzzQuil, while natural products and dietary supplements (including melatonin and herbs like Valerian) only occupy a small portion of the market. However, market research data have repeatedly shown consumers would prefer a “natural” alternative to “synthetic” OTC products. Indeed, P&G/ Vicks launched a dietary supplement under the ZzzQuil in the spring of 2018 (gummies formulated with melatonin, lavender, chamomile, valerian root and lemon balm).
The new study, led by scientists from the Sleep Center at Ewha Womans University Mokdong Hospital in Seoul, included 48 men and women with an average age of 49, and with mild to moderate degree of sleep disturbance.
The participants were randomly assigned to receive either the Lactium supplements or placebo for four weeks, followed by a four-week period with no intervention (the so-called “washout period”), before crossing over to the other intervention group for a further four weeks.
Results showed that self-reported data from sleep diaries indicated that Lactium consumption was associated with improvements in total sleep time, sleep efficiency, and sleep latency (the length of time to transition from full wakefulness to sleep), and these findings were supported by statistically significant data only from actigraphy for sleep efficiency. However, improvements in sleep latency and wake after sleep onset were trending towards statistical significance in the actigraphy measures.
“These results suggest that [Lactium] can be safely used to help individuals with sleep disturbances, especially for mild to moderate insomnia symptoms,” wrote the researchers.
“Further prospective follow-up studies with more extended administration periods should be considered for more specific assessment of cumulative [Lactium] effects without tolerance or dependence issues.”
2019, 11(7), 1466; doi: 10.3390/nu11071466
“A Double-Blind, Randomized, Placebo-Controlled Crossover Clinical Study of the Effects of Alpha-s1 Casein Hydrolysate on Sleep Disturbance”
Authors: H.J. Kim et al.