SEATTLE, WA—Patients with insomnia had “small but significant improvements” in symptoms of sleep efficiency and depth of sleep after consuming a milk product with naturally enhanced levels of melatonin and other bioactive components, results of a randomized trial reported at SLEEP 2015 have shown.
However, the milk product, iNdream3TM, which is a reduced-lactose and enriched with casein tryptic hydrolysate (CTH) “did not change objectively measured total sleep time,” noted Angela Campbell, PhD, of the University of Otago, Wellington, New Zealand.
“The size of the effects seen is similar to other nonpharmacological insomnia treatment options but smaller than those reported for commonly prescribed pharmaceutical hypnotic products,” she added.
Noting that “a naturally derived product that assisted with insomnia symptoms would have broad appeal” because many people who suffer from insomnia prefer natural alternatives, the study sought to determine whether the milk product improved sleep in patients with insomnia when compared with “day milk,” which has low melatonin and no bioactive ingredients.
The double-blind, placebo-controlled crossover trial randomized 19 adults with primary insomnia to three weeks of iNdream3 and three weeks of day milk separated by a one-week washout. Patients ranged in age from 27–73 years, 14 were female, and the Insomnia Severity Index (ISI) score ranged from 12–23.
Total sleep time, sleep efficiency, sleep onset latency, and sleep quality were measured using sleep diary and questionnaires (subjectively) and over one week for baseline and active treatment arms (objectively). Patients underwent home polysomnography at baseline and end of each arm.
Results showed that iNdream3 improved symptoms of insomnia, as compared to day milk, on the Pittsburg Sleep Quality Index, including efficiency (+5.2 vs. -0.4, P=0.039), daytime dysfunction (-0.58 vs. no change, P=0.019), and sleep related disturbance (-4.3 vs. -1.5, P= 0.011), as well as sleep onset latency by sleep diary (-8 min vs. +5 min, P=0.045).
The % stage N3 sleep by polysomnography was +8 min vs. -9 min (P=0.004), and sleep efficiency by actigraphy and number of awakenings by actigraphy also improved.
“The product was well-received and the majority felt some improvements. But we cannot determine whether the improvements were related to melatonin, low lactose, CTH, or a combination,” Dr. Campbell concluded.