Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06267586




Registration number
NCT06267586
Ethics application status
Date submitted
2/02/2024
Date registered
20/02/2024
Date last updated
24/04/2024

Titles & IDs
Public title
Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment
Scientific title
Examining the Effects of PeptiSleep, a Plant-based Sleep Aid, in Healthy Males and Females With Mild to Moderate Sleep Impairment
Secondary ID [1] 0 0
PN23.007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - PeptiSleep
Other interventions - Placebo MCC micro-crystalline cellulose

Experimental: PeptiSleep 250 mg/day - Low dose Given as 1 capsule 1 hour before bed

Experimental: PeptiSleep 500 mg/day - Middle dose Given as 2 capsules 1 hour before bed

Experimental: PeptiSleep 1000 mg/day - High dose Given as 4 capsules 1 hour before bed

Placebo Comparator: Microcrystalline Cellulose 500mg/day - Placebo Given as 2 capsules 1 hour before bed


Other interventions: PeptiSleep
Plant protein hydrolysate

Other interventions: Placebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting
Timepoint [1] 0 0
Day 0 to 56
Secondary outcome [1] 0 0
Safety via electrolytes and liver function tests
Timepoint [1] 0 0
Day 0 to 56
Secondary outcome [2] 0 0
Sleep Quality via Leeds Sleep Evaluation Questionnaire
Timepoint [2] 0 0
Day 0 to 56
Secondary outcome [3] 0 0
Insomnia severity via the Insomnia Severity Index Questionnaire
Timepoint [3] 0 0
Day 0 to 56
Secondary outcome [4] 0 0
Sleep onset time via self-reported recording in a Sleep Diary
Timepoint [4] 0 0
Day 0 to 56
Secondary outcome [5] 0 0
Sleep pattern via self-reported recording in a Sleep Diary
Timepoint [5] 0 0
Day 0 to 56
Secondary outcome [6] 0 0
Daytime Sleepiness via the Epworth Sleepiness Scale
Timepoint [6] 0 0
Day 0 to 56
Secondary outcome [7] 0 0
Stress via the Perceived Stress Scale
Timepoint [7] 0 0
Day 0 to 56
Secondary outcome [8] 0 0
Stress via self reported Profile of Mood States Questionnaire
Timepoint [8] 0 0
Day 0 to 56
Secondary outcome [9] 0 0
Anxiety via self-reported Beck Anxiety Inventory questionnaire
Timepoint [9] 0 0
Day 0 to 56
Secondary outcome [10] 0 0
Stress via Salivary cortisol test
Timepoint [10] 0 0
Day 0 to 56
Secondary outcome [11] 0 0
Alertness via Reaction Time Test
Timepoint [11] 0 0
Day 0 to 56
Secondary outcome [12] 0 0
Circadian cycles via melatonin and serotonin via blood test
Timepoint [12] 0 0
Day 0 to 56
Secondary outcome [13] 0 0
Markers associated with inflammation via blood test
Timepoint [13] 0 0
Day 0 to 56
Secondary outcome [14] 0 0
Sleep onset latency via wearable sleep tracker
Timepoint [14] 0 0
Day 0 to 56
Secondary outcome [15] 0 0
Total sleep time spent in sleep phases via wearable sleep tracker
Timepoint [15] 0 0
Day 0 to 56
Secondary outcome [16] 0 0
Blood pressure via blood pressure machine
Timepoint [16] 0 0
Day 0 to 56
Secondary outcome [17] 0 0
Heart rate via blood pressure machine
Timepoint [17] 0 0
Day 0 to 56
Secondary outcome [18] 0 0
Body Temperature via wearable sleep tracker
Timepoint [18] 0 0
Day 0 to 56
Secondary outcome [19] 0 0
BMI via height and weight measurements
Timepoint [19] 0 0
Day 0 to 56

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/02/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Fortitude Valley QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nuritas Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
RDC Clinical Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females
with mild to moderate sleep impairment
Trial website
https://clinicaltrials.gov/ct2/show/NCT06267586
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Niamh Mohan, PhD
Address 0 0
Country 0 0
Phone 0 0
+353 1 430 1290
Fax 0 0
Email 0 0
mohan.niamh@nuritas.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06267586