NCT06267586

Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment

Examining the Effects of PeptiSleep, a Plant-based Sleep Aid, in Healthy Males and Females With Mild to Moderate Sleep Impairment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nuritas Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment

Detailed description

The primary aim of this is a first in human study is to evaluate safety and establish the effective dose in males and females who experience mild to moderate sleep impairment, but who are otherwise healthy. PeptiSleep will be supplemented one hour before bed as a single oral dose of either 250mg, 500mg or 1000mg/day. A placebo group will also be included who will receive 500mg of microcrystalline cellulose. This trial incorporates a sleep tracking element to measure sleep quality and quantity via a ring which will be worn by participants for the duration of the study. The trial will be conducted over 10 weeks, which includes a 2 week run-in period to gather baseline sleep data, followed by 8 weeks of PeptiSleep supplementation and sleep tracking. The primary endpoint will measure safety and tolerability via adverse event reporting and incidence rate ratio between placebo and PeptiSleep from baseline to the end of the study period. Secondary endpoints investigated during the trial will include changes sleep quantity and quality, insomnia severity, daytime sleepiness, stress and anxiety, alertness, and biochemistry markers (melatonin, serotonin, CRP, TNFα, IL-6, E/LFT). Exploratory endpoints will include various sleep metrics measured via the wearable tracker including heart rate variability, sleep efficiency, respiratory rate, blood oxygen sensing and daily readiness score.

Conditions

• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PeptiSleep	Plant protein hydrolysate
DIETARY_SUPPLEMENT	Placebo MCC micro-crystalline cellulose	Placebo MCC micro-crystalline cellulose

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-12-30
• Completion: 2025-03-01
• First posted: 2024-02-20
• Last updated: 2025-03-13

Locations

1 site across 1 country: Australia