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Randomized Controlled Trial
, 11 (7)

A Double-Blind, Randomized, Placebo-Controlled Crossover Clinical Study of the Effects of Alpha-s1 Casein Hydrolysate on Sleep Disturbance

Randomized Controlled Trial

A Double-Blind, Randomized, Placebo-Controlled Crossover Clinical Study of the Effects of Alpha-s1 Casein Hydrolysate on Sleep Disturbance

Hyeon Jin Kim et al. Nutrients.


This study evaluated the effects of alpha-s1 casein hydrolysate (ACH; Lactium®) on the subjective and objective sleep profiles of a community-based sample of Koreans with poor sleep quality. We performed a double-blind, randomized crossover trial with 48 participants (49.0 ± 1.7 years old, 65% female) who exhibited a mild to moderate degree of sleep disturbance. Either ACH or placebo was administered for the initial four weeks, and the counterpart was administered in precisely the same manner after a four-week washout period. Sleep disturbance scales, daytime functioning, and psychiatric aspects showed a similar tendency to improve during both ACH and placebo phases without significant group differences. Overall perceived sleep profiles in sleep diaries were significantly improved during the ACH phase, represented by increased total sleep time and sleep efficiency (SE), as well as decreased sleep latency and wake after sleep onset (WASO). Interestingly, actigraphy demonstrated significantly increased SE after continuous use of ACH for four weeks, clearly more improved when compared to two weeks of use. The polysomnography measures showed a similar tendency without statistically significant group differences. Our findings suggest that refined ACH was well tolerated and could improve sleep quality, with possible cumulative beneficial effects with long-term administration.

Keywords: Lactium®; alpha-s1 casein hydrolysate; clinical trial; insomnia; nutritional supplements; sleep disturbance; sleep quality.

Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.


Figure 1
Figure 1
Study protocol. ACH, alpha-s1 casein hydrolysate.
Figure 2
Figure 2
Comparison of effects of ACH administration duration on sleep efficiency. (a) Sleep diary showed constant improvement in sleep efficiency for ACH phase group compared with gradual deterioration for placebo group. Group difference in sleep efficiency over time became significant when ACH was administered for four weeks (p < 0.001, q < 0.001 for 0–4 weeks), which did not reach statistical significance after two weeks of use (p = 0.067 for 0–2 weeks). (b) Actigraphy revealed that sleep efficiency did not show clear differences between ACH and placebo phases; however, the significant improvement effect was only obvious after continuous use of ACH for four weeks (p = 0.066 for 0–2 weeks vs. p = 0.007, q = 0.016 for 0–4 weeks). * q-value < 0.05 and ** q-value < 0.01, pFDR was calculated for group × time difference by linear mixed-effects model to account for multiple testing.

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