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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06267586
Registration number
NCT06267586
Ethics application status
Date submitted
2/02/2024
Date registered
20/02/2024
Titles & IDs
Public title
Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment
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Scientific title
Examining the Effects of PeptiSleep, a Plant-based Sleep Aid, in Healthy Males and Females With Mild to Moderate Sleep Impairment
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Secondary ID [1]
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PN23.007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - PeptiSleep
Treatment: Other - 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
Treatment: Other: PeptiSleep
Plant protein hydrolysate
Treatment: Other: Placebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting
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Assessment method [1]
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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
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Timepoint [1]
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Day 0 to 56
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Secondary outcome [1]
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Safety via electrolytes and liver function tests
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Assessment method [1]
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Change from baseline to the end of the study period in safety including electrolytes and liver function markers via blood test
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Timepoint [1]
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Day 0 to 56
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Secondary outcome [2]
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Sleep Quality via Leeds Sleep Evaluation Questionnaire
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Assessment method [2]
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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
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Timepoint [2]
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Day 0 to 56
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Secondary outcome [3]
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Insomnia severity via the Insomnia Severity Index Questionnaire
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Assessment method [3]
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Change from baseline to the end of the study period in Insomnia Severity via Insomnia Severity Index (ISI). The questionnaire has seven questions. The seven answers are added up to get a total score.
Total score categories:
* 0-7 = No clinically significant insomnia
* 8-14 = Subthreshold insomnia
* 15-21 = Clinical insomnia (moderate severity)
* 22-28 = Clinical insomnia (severe)
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Timepoint [3]
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Day 0 to 56
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Secondary outcome [4]
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Sleep onset time via self-reported recording in a Sleep Diary
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Assessment method [4]
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Change from baseline to the end of the study period in Sleep Onset Time via Consensus Sleep Diary (CSD)
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Timepoint [4]
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Day 0 to 56
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Secondary outcome [5]
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Sleep pattern via self-reported recording in a Sleep Diary
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Assessment method [5]
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Change from baseline to the end of the study period in self reported Sleeping Pattern and number of Disturbance as recorded using a Consensus Sleep Diary (CSD)
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Timepoint [5]
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Day 0 to 56
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Secondary outcome [6]
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Daytime Sleepiness via the Epworth Sleepiness Scale
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Assessment method [6]
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Change from baseline to the end of the study period in Day Time Sleepiness and Nap Count via the Epworth Sleepiness Scale (ESS). The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher the propensity for daytime sleepiness
* Scores 0-5 Lower Normal Daytime Sleepiness
* Scores 6-10 Higher Normal Daytime Sleepiness
* Scores 11-12 Mild Excessive Daytime Sleepiness
* Scores 13-15 Moderate Excessive Daytime Sleepiness
* Scores 16-24 Severe Excessive Daytime Sleepiness.
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Timepoint [6]
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Day 0 to 56
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Secondary outcome [7]
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Stress via the Perceived Stress Scale
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Assessment method [7]
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Change from baseline to the end of the study period in Stress via a self reported questionnaire - Perceived Stress Scale (PSS). The questions in this scale ask about feelings and thoughts during the last month. The questionnaire asks the participant to indicate how often they felt or thought a certain way with 0 meaning never and 4 meaning very often.
PSS scores are calculated by:
* First, reverse your scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
* Add up your scores for each item to get a total.
* Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
* Scores ranging from 0-13 would be considered low stress.
* Scores ranging from 14-26 would be considered moderate stress.
* Scores ranging from 27-40 would be considered high perceived stress
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Timepoint [7]
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Day 0 to 56
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Secondary outcome [8]
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Stress via self reported Profile of Mood States Questionnaire
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Assessment method [8]
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Change from baseline to the end of the study period in Stress via a self reported questionnaire called Profile of Mood States (POMS). The questionnaire contains 65 words that describe feelings which are rated from 0-4. Scores are calculated:
* Tension = Tense, Shaky, On Edge, Panicky, Relaxed, Uneasy, Restless, Nervous and Anxious
* Depression = Unhappy, Sorry for Things Done, Sad, Blue, Hopeless, Unworthy, Discouraged, Lonely, Miserable, Gloomy, Desperate, Helpless, Worthless, Terrified and Guilty
* Anger = Anger, Peeved, Grouchy, Spiteful, Annoyed, Resentful, Bitter, Ready to Fight, Rebellious, Deceived, Furious and Bad Tempered
* Fatigue = Worn Out, Listless, Fatigued, Exhausted, Sluggish, Weary and Bushed
* Confusion= Confused, Unable to Concentrate, Muddled, Bewildered, Efficient, Forgetful, and Uncertain About Things
* Vigour =Lively, Active, Energetic, Cheerful, Alert, Full of Pep, Carefree and Vigorous
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Timepoint [8]
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Day 0 to 56
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Secondary outcome [9]
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Anxiety via self-reported Beck Anxiety Inventory questionnaire
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Assessment method [9]
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Change from baseline to the end of the study period in Anxiety via Beck Anxiety Inventory (BAI) questionnaire. The BAI consists of 21 self-reported items on a four-point scale - ''not at all'' (0) to ''severely'' (3) to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63
* Minimal anxiety levels (0-7)
* Mild anxiety (8-15)
* Moderate anxiety (16-25)
* Severe anxiety (26-63)
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Timepoint [9]
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Day 0 to 56
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Secondary outcome [10]
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Stress via Salivary cortisol test
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Assessment method [10]
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Change from baseline to the end of the study period in Stress via Salivary cortisol test
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Timepoint [10]
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Day 0 to 56
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Secondary outcome [11]
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Alertness via Reaction Time Test
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Assessment method [11]
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Change from baseline to the end of the study period in Alertness via Reaction Time Test
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Timepoint [11]
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Day 0 to 56
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Secondary outcome [12]
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Circadian cycles via melatonin and serotonin via blood test
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Assessment method [12]
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Change from baseline to the end of the study period in markers associated with circadian cycles - melatonin and serotonin via blood test
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Timepoint [12]
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Day 0 to 56
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Secondary outcome [13]
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Markers associated with inflammation via blood test
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Assessment method [13]
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Change from baseline to the end of the study period in Inflammatory Markers such as CRP, TNF-a and IL-6 via blood test
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Timepoint [13]
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Day 0 to 56
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Secondary outcome [14]
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Sleep onset latency via wearable sleep tracker
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Assessment method [14]
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Change from baseline to the end of the study sleep onset latency measured in minutes using a wearable sleep tracker
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Timepoint [14]
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Day 0 to 56
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Secondary outcome [15]
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Total sleep time spent in sleep phases via wearable sleep tracker
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Assessment method [15]
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Change from baseline to the end of the study in total sleep time during phases of light, deep and REM sleep measured in minutes via a wearable sleep tracker
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Timepoint [15]
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Day 0 to 56
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Secondary outcome [16]
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Blood pressure via blood pressure machine
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Assessment method [16]
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Change from baseline to the end of the study in blood pressure measured in mmHG
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Timepoint [16]
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Day 0 to 56
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Secondary outcome [17]
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Heart rate via blood pressure machine
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Assessment method [17]
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Change from baseline to the end of the study in heart rate measured in beats per minute using a blood pressure machine
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Timepoint [17]
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Day 0 to 56
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Secondary outcome [18]
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Body Temperature via wearable sleep tracker
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Assessment method [18]
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Change from baseline to the end of the study in body temperature measured in Celsius using a wearable sleep tracker
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Timepoint [18]
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Day 0 to 56
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Secondary outcome [19]
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BMI via height and weight measurements
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Assessment method [19]
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Change from baseline to the end of the study in BMI. The BMI is calculated by dividing weight in kilograms by height in meters squared and is measured in kg/m2.
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Timepoint [19]
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Day 0 to 56
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
20/02/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
Fortitude Valley QLD
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Recruitment hospital [1]
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RDC Clinical - Brisbane
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Nuritas Ltd
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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RDC Clinical Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment
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Trial website
https://clinicaltrials.gov/study/NCT06267586
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Niamh Mohan, PhD
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Address
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Country
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Phone
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+353 1 430 1290
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06267586