RecruitingNot ApplicableNCT07258433

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

Sponsor

Nuritas Ltd

Enrollment

120 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Wearable Technology Sleep Healthy Participants Cortisol Cognitive Abilities

Summary

Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria13

Adults aged 18-65 at the time of enrollment.
Generally healthy
BMI 18.5 - 35.0kg/m2
Willing and able to provide informed consent.
Willing to consume one PeptiSleep or placebo capsule daily for 6 weeks.
Willing to wear a sleep tracker continuously throughout the study period.
Willing to complete all scheduled surveys and cognitive assessments on Days 0, 1, 2, and 3, at biweekly check-ins (Week 2 and Week 4), and at End-of-Study (Day 42).
Willing to sync their wearable device data through the Reputable Health app and complete daily check-ins for compliance assessment
Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
Agree to maintain a stable lifestyle and medication routines for at least 4 weeks prior to enrollment
Agree not to use other medicines or supplements for sleep, stress, depression, or anxiety other than the test product during enrolment period.
Agree to refrain from participation in another clinical trial during enrolment period.
Agree to comply with Creyos digital platform data usage and privacy policy

Exclusion Criteria21

Are currently pregnant, breastfeeding, or planning pregnancy during the study period.
Are using prescription or over-the-counter sleep medications (e.g., zolpidem, melatonin \>5 mg, benzodiazepines, CBD or antihistamines used for sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
Have a current diagnosis of a chronic medical condition or illness (e.g., uncontrolled thyroid disease, diabetes, cardiovascular disease, major depressive disorder, or anxiety disorder requiring ongoing pharmacologic treatment) or a chronic sleep disorder, insomnia, restless leg syndrome, sleep apnoea.
Are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 4-weeks and any other sleep clinical trial during the past 3 months.
Have a known allergy or sensitivity to any component of the investigational or placebo product
Are shift workers or have highly irregular sleep/wake schedules that could confound study outcomes.
Are unable or unwilling to comply with daily product use, wearable requirements, or survey/assessment completion.
Have with significant non-wear time of their Oura device exceeding a 48- hour period
Are using medications which induce CYP3A4 such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids.
Are using prescription or OTC medications or supplements for sleep, stress, depression, or anxiety including CBD within one month prior to enrolment.
Are using aromatherapy to help manage sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
Are using a digital device (besides Oura) to help monitor or manage sleep during the study period.
Have a current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
Have been diagnosed with or have consistent gastrointestinal issues that disrupt sleep.
Have a history of renal function impairment
Have with COPD or a chronic breathing disorder
Are active smokers, nicotine use or drug (prescription or illegal substances) abuse.
Have a chronic past and/or current alcohol use (\>14 alcoholic drinks week)
Are regularly taking stimulants (e.g., coffee, caffeine supplements, beverages containing caffeine) 5 hours before bed
Are regularly consuming more than 500mg of caffeine per day
Have any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.