In part 1 we discussed the why behind our product as well as the science behind the individual ingredients alpha-lactalbumin and tart cherry extract. Today we will share how we designed our scientific study and of course what our initial results are!
Once we had the two powerhouse ingredients nailed down and turned it into a nice tasting beverage by adding some natural flavorings like cocoa, it was time to put the product to the test.
Study design
There are different levels of rigor one could go for when designing a study. Given that we wanted others to believe in the product as much as we do, we went for the most rigorous study design out there: a double-blind, randomized, cross-over study, including 3 treatments: the product, placebo and distilled water. The placebo looked and tasted the same as our product but did not have the active ingredients in it.
So what does it mean when a study is “double-blind, randomized, cross-over”?
Double blind: neither the investigators nor subjects know which treatment (real treatment or placebo) is provided. Of course, people can figure out when they are drinking water.
Randomized: The order in which the interventions are provided is randomized. Some will receive the treatment first, others the placebo and again others will start with water.
Cross-over: every subject receives ALL treatments. So, the subjects receive either real treatment or placebo(s) for a time, and then are switched (crossed over) to the opposite treatment.
Measuring tool:
To measure the duration and quality of sleep we used the Sleep Profile: An in-home, subject-applied, objective-assessment of sleep architecture and continuity. It yields comparable sleep architecture estimates to full PSG or in-lab measurements. The best we can do without getting people into a sleep lab.
Recruitment and process:
We recruited health, non-sleep disturbed subjects. Subjects were first screened for sleep apnea and then consumed each of the three treatments for 3 consecutive nights. An 11-night washout period was used between each treatment. Subjects were asked to notify the investigators if anything out of the ordinary disturbed their sleep during data collection nights. If any of these events occurred, the data from that night were excluded from the analyses.
Results
Of course, we were eager for great results. The existing science gave us some hope but that it would work this well was beyond what any of us (including the investigators) could hope of. We’ll be sharing the initial results in this article. If you are interested in the details of it all, sign up and we’ll share the white paper with you as soon as it’s ready.
Significantly more sleep
For subjects taking our product, the average total sleep time was 1h 12min greater than placebo and 54min greater than water. That is a 20.7% and 14.8% increase in sleep compared to placebo and distilled water respectively.
Fewer bad nights
Most adults need 7-9 hours of sleep per night to function at their best. Generally speaking, consistently getting less than 7 hours of sleep per night can lead to negative effects on both physical and mental health.
With this in mind, we can safely say that sleeping <6 hours is considered a bad night of sleep. Subjects consuming the placebo and distilled water treatment had 267% and 300% more bad nights respectively.
Improvement in all sleep phases
Improvement in all sleep phases was seen but the effect was most pronounced in the N2 sleep phase, followed by N3 and REM.
The N2 sleep phase is associated with memory consolidation and improvement in this phase may promote cognitive and motor learning capabilities. When speaking about the warfighter, for which the product was initially designed, this would be beneficial for e.g. learning mission tasks and mission details. Generally speaking, it would benefit anyone who needs their cognitive and motor learning capabilities to perform during the day.
Anecdotal
We did not measure this officially, but subjects disclosed that they “felt better” or “could think more clearly” on days following consumption of the treatment. They did not report such observations following the placebo or water treatments.
Now that the product is not only available to elite groups and the warfighter but also to the general population, we are keen to hear what your experience with it is. So try it out and let us know what you think!
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