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

NCT06267586 | Completed

• 1 other identifier: PN23.007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting

  Change from baseline to the end of the study period in safety via adverse event reporting and incident rate ratio between placebo and a dose range of PeptiSleep

  Day 0 to 56

Secondary Outcomes (19)

• Safety via electrolytes and liver function tests

  Day 0 to 56

• Sleep Quality via Leeds Sleep Evaluation Questionnaire

  Day 0 to 56

• Insomnia severity via the Insomnia Severity Index Questionnaire

  Day 0 to 56

• Sleep onset time via self-reported recording in a Sleep Diary

  Day 0 to 56

• Sleep pattern via self-reported recording in a Sleep Diary

  Day 0 to 56

Other Outcomes (10)

• Bedtime via wearable sleep tracker

  Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation

• Total time awake via wearable sleep tracker

  Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation

• Sleep quantity via wearable sleep tracker

  Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation

Study Arms (4)

PeptiSleep 250 mg/day

EXPERIMENTAL

Low dose Given as 1 capsule 1 hour before bed

Dietary Supplement: PeptiSleep

PeptiSleep 500 mg/day

EXPERIMENTAL

Middle dose Given as 2 capsules 1 hour before bed

Dietary Supplement: PeptiSleep

PeptiSleep 1000 mg/day

EXPERIMENTAL

High dose Given as 4 capsules 1 hour before bed

Dietary Supplement: PeptiSleep

Microcrystalline Cellulose 500mg/day

PLACEBO COMPARATOR

Placebo Given as 2 capsules 1 hour before bed

Dietary Supplement: Placebo MCC micro-crystalline cellulose

Interventions

PeptiSleep DIETARY_SUPPLEMENT

Plant protein hydrolysate

PeptiSleep 1000 mg/day; PeptiSleep 250 mg/day; PeptiSleep 500 mg/day

Placebo MCC micro-crystalline cellulose DIETARY_SUPPLEMENT

Placebo MCC micro-crystalline cellulose

Microcrystalline Cellulose 500mg/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:

• Males and females 18-65 years
• Generally healthy
• BMI 18.5 - 33.0.kg/m2
• Volunteers who score 0-14 on the ISI screening questionnaire (to exclude insomniacs)
• Those with an average sleep score of 89 or less as determined by the sleep tracker during the 14-day run-in period
• Must be willing to wear the sleep tracker for the duration of their enrolment
• Able to provide informed consent
• Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period
• Agree not to use other medicines or supplements for sleep, stress, depression, or anxiety other than the test product during enrolment period
• Agree to not participate in another clinical trial during enrolment period

You may not qualify if:

• Those diagnosed with a chronic sleep disorder, insomnia, restless leg syndrome, sleep apnoea or score of 15 or more on ISI questionnaire
• Those with an average sleep score of 90 or over as determined by the sleep tracker during the 14-day run-in period
• Those deemed unsuitable based on data from the sleep tracker measurements collected during the 14-day run in period i.e., those with non-wear time exceeding a 24-hour period on more than one occasion
• Those using medications which induce CYP3A4 such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids.
• Those using prescription or OTC medications or supplements for sleep, stress, depression or anxiety including CBD within 1 month prior to enrolment.
• Those using aromatherapy to help manage sleep, stress, depression, or anxiety within 1 month prior to enrolment.
• Use of a digital device (besides the supplied sleep tracker) to help monitor or manage sleep during the study period.
• Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
• Serious illness1 e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
• Unstable illness2 e.g., diabetes and thyroid gland dysfunction
• Diagnosed or consistent gastrointestinal issues that disrupt sleep.
• History of renal function impairment
• Volunteers with COPD or a chronic breathing disorder
• Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
• Active smokers, nicotine use or drug (prescription or illegal substances) abuse

Sponsors & Collaborators

• Nuritas Ltd: lead
• RDC Clinical Pty Ltd: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Fortitude Valley Queensland, 4006, Australia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of arm allocation however as each arm contains a different number of capsules to be consumed, the investigator will be aware of the arm allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, placebo-controlled, parallel dose response study conducted over 70 days

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: April 8, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)