Effects of PeptiSleep on Sleep Quality in Healthy Adults

NCT07258433 | Completed

• 1 other identifier: PEPSLE2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Sleep; Decentralised Study; Peptide Therapeutics; Protein Hydrolysates; Sleep Quality; Leeds Sleep Evaluation Questionnaire; Creyos; Oura; Wearable Technology

Outcome Measures

Primary Outcomes (1)

• Sleep Quality via Leeds Sleep Evaluation Questionnaire

  Change from baseline to the end of the study period in Sleep Quality via Leeds Sleep Evaluation Questionnaire (LSEQ). The LSEQ comprises ten self-rating 100-mm-line analogue questions concerned with aspects of sleep and early morning behaviour. A visual analogue scale is used with two extreme states defined at the ends of the line (e. g. Tired = score of 0, Alert = score of 10). The subject responds by placing a vertical mark on the line to indicate his present self- evaluation. The four subscales are as follows: * The ease of getting to sleep (GTS), questions 1-3 * The perceived quality of sleep (QOS), questions 4-5 * The easy of awakening from sleep (AFS), questions 6-7 * The integrity of behaviour following wakefulness (BFW), questions, 8-10

  Day 0 to Day 42

Secondary Outcomes (12)

• Sleep Quality via Pittsburgh Sleep Quality Index

  Day 0 to Day 42

• Heart Rate Variability via Wearable Technology

  Day 0 to Day 42

• Nocturnal Heart Rate via Wearable Technology

  Day 0 to Day 42

• Sleep Onset Latency via Wearable Technology

  Day 0 to Day 42

• Sleep Architecture via Wearable Technology

  Day 0 to Day 42

Study Arms (2)

PeptiSleep 250 mg/day

EXPERIMENTAL

One capsule to be consumed orally 30-60 minutes before bed

Dietary Supplement: PeptiSleep

Microcrystalline Cellulose 250 mg/day

PLACEBO COMPARATOR

One capsule to be consumed orally 30-60 minutes before bed

Dietary Supplement: Micro-crystalline cellulose

Interventions

PeptiSleep DIETARY_SUPPLEMENT

Rice Protein Hydrolysate

PeptiSleep 250 mg/day

Micro-crystalline cellulose DIETARY_SUPPLEMENT

Placebo MCC micro-crystalline cellulose

Microcrystalline Cellulose 250 mg/day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reputable Health: collaborator
• Nuritas Ltd: lead

Study Sites (1)

Reputable Labs Inc.

Wilmington, Delaware, 19808, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mackenzie De Jesus, DHSc, MS

  Reputable Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Decentralised, Double-Blind, Placebo-Controlled, Parallel-Design study conducted over 6-weeks

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: December 29, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 28, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)