protocolSection identificationModule nctId: NCT06267586, orgStudyIdInfo id: PN23.007, briefTitle: Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nuritas Ltd, class: INDUSTRY, collaborators name: RDC Clinical Pty Ltd, descriptionModule briefSummary: Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment, conditionsModule conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, single-blind, placebo-controlled, parallel dose response study conducted over 70 days, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: 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, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: PeptiSleep, interventions name: Placebo MCC micro-crystalline cellulose, outcomesModule primaryOutcomes measure: Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting, secondaryOutcomes measure: Safety via electrolytes and liver function tests, secondaryOutcomes measure: Sleep Quality via Leeds Sleep Evaluation Questionnaire, secondaryOutcomes measure: Insomnia severity via the Insomnia Severity Index Questionnaire, secondaryOutcomes measure: Sleep onset time via self-reported recording in a Sleep Diary, secondaryOutcomes measure: Sleep pattern via self-reported recording in a Sleep Diary, secondaryOutcomes measure: Daytime Sleepiness via the Epworth Sleepiness Scale, secondaryOutcomes measure: Stress via the Perceived Stress Scale, secondaryOutcomes measure: Stress via self reported Profile of Mood States Questionnaire, secondaryOutcomes measure: Anxiety via self-reported Beck Anxiety Inventory questionnaire, secondaryOutcomes measure: Stress via Salivary cortisol test, secondaryOutcomes measure: Alertness via Reaction Time Test, secondaryOutcomes measure: Circadian cycles via melatonin and serotonin via blood test, secondaryOutcomes measure: Markers associated with inflammation via blood test, secondaryOutcomes measure: Sleep onset latency via wearable sleep tracker, secondaryOutcomes measure: Total sleep time spent in sleep phases via wearable sleep tracker, secondaryOutcomes measure: Blood pressure via blood pressure machine, secondaryOutcomes measure: Heart rate via blood pressure machine, secondaryOutcomes measure: Body Temperature via wearable sleep tracker, secondaryOutcomes measure: BMI via height and weight measurements, otherOutcomes measure: Bedtime via wearable sleep tracker, otherOutcomes measure: Total time awake via wearable sleep tracker, otherOutcomes measure: Sleep quantity via wearable sleep tracker, otherOutcomes measure: Sleep efficiency via wearable sleep tracker, otherOutcomes measure: Sleep score via wearable sleep tracker, otherOutcomes measure: Nocturnal heart rate via wearable sleep tracker, otherOutcomes measure: Heart Rate variability via wearable sleep tracker, otherOutcomes measure: Blood Oxygen sensing via sleep tracker, otherOutcomes measure: Respiratory rate via sleep tracker, otherOutcomes measure: Daily Readiness Score via sleep tracker, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RDC Clinical, status: RECRUITING, city: Brisbane, state: Fortitude Valley Queensland, zip: 4006, country: Australia, contacts name: Amanda Rao, role: CONTACT, contacts name: Amanda Rao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False