NCT07258433

Effects of PeptiSleep on Sleep Quality in Healthy Adults

A Randomized, Double-Blind, Placebo-Controlled, 6-Week Decentralised Trial Evaluating the Effects of PeptiSleep on Sleep Quality in Healthy Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• 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, on sleep quality in healthy adults

Detailed description

The primary aim of this is double-blind placebo-controlled parallel-design study is to measure the effects of PeptiSleep on sleep quality in healthy adults. PeptiSleep will be supplemented 30-60 minutes before bed as a single oral dose of 250mg for 6-weeks. A placebo group will also be included who will receive a matched dose of microcrystalline cellulose in identical capsules. This trial incorporates a wearable sleep tracker to measure sleep biometrics which will be worn by participants for the duration of the study, as well as clinically validated questionnaires to measure sleep quality and a digital cognitive battery for to assess next day performance. The trial will be conducted over 6-weeks. 4 weeks of sleep tracking data will serve as a baseline prior to initiation of the supplementation period. The trial is fully decentralised. The primary endpoint will measure the effects of PeptiSleep supplementation on responsive sleep quality via Leeds Sleep Evaluation Questionnaire versus a placebo from baseline to the end of the study period. Secondary endpoints investigated during the trial will include changes in sleep biometrics (cardiac measures, sleep architecture, latency etc.) via Oura wearable, changes in comprehensive sleep quantity via Pittsburgh Sleep Quality Index (PSQI), next day readiness and next day performance via Creyos digital testing platform and safety and tolerability via adverse event reporting.

Conditions

• Sleep
• Wearable Technology
• Cortisol
• Healthy Participants
• Cognitive Abilities

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PeptiSleep	Rice Protein Hydrolysate
DIETARY_SUPPLEMENT	Micro-crystalline cellulose	Placebo MCC micro-crystalline cellulose

Timeline

• Start date: 2025-12-29
• Primary completion: 2026-02-28
• Completion: 2026-03-28
• First posted: 2025-12-02
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States