Hydrolyzed casein peptides improve sleep quality by remodeling gut microbiota and activating tryptophan-melatonin pathway:a randomized,double-blind,placebo-controlled clinical trial
Objective To evaluated the effect of low-(500 mg/d)and high-dose(1 000 mg/d)of hydrolyzed casein pep-tide(HCP-2hvy)in improvement of the sleep quality of patients with insomnia and analyze the mechanism of action in terms of intestinal microbiota,using placebo(tablet vehicle)as the control.Methods A randomized,double-blind,placebo-controlled clinical trial was conducted,in which 82 patients were divided into the low-dose,high-dose and placebo group respectively.HCP-2hvy or placebo was administered qd for 14 days.Sleep diaries and sleep monitoring data as well as blood and fecal samples were collected and analyzed before and after the treatment.Results Both low-and high-dose HCP-2hvy significantly prolonged the total objective sleep time of the patients compared to the placebo group(t=2.870,P=0.005 in the low-dose group and t=2.590,P=0.010 in the high-dose group).High-dose HCP-2hvy significantly in-creased the Shannon index of gut microbiota(t=2.716,P=0.008);both the low-and high-dose groups significantly in-creased the Simpson index(t=2.066,P=0.041 in the low-dose group,and t=3.221,P=0.002 in the high-dose group),and both groups showed a CPCoA of the microbiota(P=0.048)significantly separated from that in the placebo group.Low-and high-dose of HCP-2hvy increased the relative abundances of intestinal Faecalibacterium_prausnitzii(t=2.146,P=0.036)and Romboutsia_timonensis(t=2.263,P=0.027),respectively.Conclusion HCP-2hvy may improve sleep quality in in-somniacs by regulating intestinal microbiota,Which may therefore be promoted as a dietary supplement to improve insom-nia.
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