Clinical trial NCT06267586: Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment
Official title: Examining the Effects of PeptiSleep, a Plant-based Sleep Aid, in Healthy Males and Females With Mild to Moderate Sleep Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Nuritas Ltd
Sponsor class: INDUSTRY
Collaborators: name: RDC Clinical Pty Ltd
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind, placebo-controlled, parallel dose response study conducted over 70 days
Primary purpose: OTHER

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

Detailed description: The primary aim of this is a first in human study is to evaluate safety and establish the effective dose in males and females who experience mild to moderate sleep impairment, but who are otherwise healthy. PeptiSleep will be supplemented one hour before bed as a single oral dose of either 250mg, 500mg or 1000mg/day. A placebo group will also be included who will receive 500mg of microcrystalline cellulose.

This trial incorporates a sleep tracking element to measure sleep quality and quantity via a ring which will be worn by participants for the duration of the study. The trial will be conducted over 10 weeks, which includes a 2 week run-in period to gather baseline sleep data, followed by 8 weeks of PeptiSleep supplementation and sleep tracking.

The primary endpoint will measure safety and tolerability via adverse event reporting and incidence rate ratio between placebo and PeptiSleep from baseline to the end of the study period.

Secondary endpoints investigated during the trial will include changes sleep quantity and quality, insomnia severity, daytime sleepiness, stress and anxiety, alertness, and biochemistry markers (melatonin, serotonin, CRP, TNFα, IL-6, E/LFT).

Exploratory endpoints will include various sleep metrics measured via the wearable tracker including heart rate variability, sleep efficiency, respiratory rate, blood oxygen sensing and daily readiness score.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Regularly taking stimulants (e.g., coffee, caffeine supplements, beverages containing caffeine) 5 hours before bed
* Regularly consuming more than 500mg of caffeine per day
* Those working night-shift employment who are unable to have a normal night's sleep.
* Disturbed sleeping pattern caused by external factors (e.g., young children, partner etc.)
* Pregnant or lactating women
* Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month and any other sleep clinical trial during the past 3 months.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.

  1. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
  2. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.

Primary outcomes:
measure: Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting
timeFrame: Day 0 to 56
Secondary outcomes:
measure: Safety via electrolytes and liver function tests
timeFrame: Day 0 to 56
measure: Sleep Quality via Leeds Sleep Evaluation Questionnaire
timeFrame: Day 0 to 56
measure: Insomnia severity via the Insomnia Severity Index Questionnaire
timeFrame: Day 0 to 56
measure: Sleep onset time via self-reported recording in a Sleep Diary
timeFrame: Day 0 to 56
measure: Sleep pattern via self-reported recording in a Sleep Diary
timeFrame: Day 0 to 56
measure: Daytime Sleepiness via the Epworth Sleepiness Scale
timeFrame: Day 0 to 56
measure: Stress via the Perceived Stress Scale
timeFrame: Day 0 to 56
measure: Stress via self reported Profile of Mood States Questionnaire
timeFrame: Day 0 to 56
measure: Anxiety via self-reported Beck Anxiety Inventory questionnaire
timeFrame: Day 0 to 56
measure: Stress via Salivary cortisol test
timeFrame: Day 0 to 56
measure: Alertness via Reaction Time Test
timeFrame: Day 0 to 56
measure: Circadian cycles via melatonin and serotonin via blood test
timeFrame: Day 0 to 56
measure: Markers associated with inflammation via blood test
timeFrame: Day 0 to 56
measure: Sleep onset latency via wearable sleep tracker
timeFrame: Day 0 to 56
measure: Total sleep time spent in sleep phases via wearable sleep tracker
timeFrame: Day 0 to 56
measure: Blood pressure via blood pressure machine
timeFrame: Day 0 to 56
measure: Heart rate via blood pressure machine
timeFrame: Day 0 to 56
measure: Body Temperature via wearable sleep tracker
timeFrame: Day 0 to 56
measure: BMI via height and weight measurements
timeFrame: Day 0 to 56
Other outcomes:
measure: Bedtime via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Total time awake via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Sleep quantity via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Sleep efficiency via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Sleep score via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Nocturnal heart rate via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Heart Rate variability via wearable sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Blood Oxygen sensing via sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Respiratory rate via sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
measure: Daily Readiness Score via sleep tracker
timeFrame: Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Fortitude Valley Queensland
Study officials:
References: