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

Sleep Clinical Trial

Official title:

Examining the Effects of PeptiSleep, a Plant-based Sleep Aid, in Healthy Males and Females With Mild to Moderate Sleep Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267586
• Other study ID #: PN23.007
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: February 20, 2025

Study information

• Verified date: April 2024
• Source: Nuritas Ltd
• Contact: Niamh Mohan, PhD
• Phone: +353 1 430 1290
• Email: mohan.niamh[@]nuritas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 20, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• PeptiSleep
Plant protein hydrolysate
• Placebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose

Locations

Country	Name	City	State
Australia	RDC Clinical	Brisbane	Fortitude Valley Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Nuritas Ltd	RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bedtime via wearable sleep tracker	Changes over the course of the study in Bedtime as an estimate of initial period intending to sleep as measured via a wearable sleep tracker	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Total time awake via wearable sleep tracker	Changes over the course of the study in Total time awake in minutes via a wearable sleep tracker	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Sleep quantity via wearable sleep tracker	Changes over the course of the study in Sleep quantity measured as the number of hours between bedtime and wake-up time via a wearable sleep tracker	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Sleep efficiency via wearable sleep tracker	Changes over the course of the study in Sleep efficiency. Sleep efficiency is the percentage of time spent asleep while in bed. It is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes). A normal sleep efficiency is considered to be 85% or higher.	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Sleep score via wearable sleep tracker	Changes over the course of the study in Sleep score Sleep Score ranges 0-100.; Scores 85 or higher: Optimal; Scores 70-84: Good; Under 70: Poor	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Nocturnal heart rate via wearable sleep tracker	Changes over the course of the study in Nocturnal heart rate, the number of heart beats per minute while at rest via a wearable sleep tracker	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Heart Rate variability via wearable sleep tracker	Changes over the course of the study in Heart Rate variability recorded as the time interval between two heartbeats in milliseconds via a wearable sleep tracker	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Blood Oxygen sensing via sleep tracker	Changes over the course of the study in Blood Oxygen sensing as measured via the sleep tracking device	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Respiratory rate via sleep tracker	Changes over the course of the study in respiratory rate as measured via the sleep tracking device	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Other	Daily Readiness Score via sleep tracker	Changes over the course of the study in Daily Readiness Score Readiness Score ranges 0-100.; Scores 85 or higher: Optimal; Scores 70-84: Good; Under 70: Poor	Day -12 to 0 and Day 0 to 56. Run in period will identify sleep pattern prior to supplementation
Primary	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	Safety via electrolytes and liver function tests	Change from baseline to the end of the study period in safety including electrolytes and liver function markers via blood test	Day 0 to 56
Secondary	Sleep Quality via Leeds Sleep Evaluation Questionnaire	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	Day 0 to 56
Secondary	Insomnia severity via the Insomnia Severity Index Questionnaire	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)	Day 0 to 56
Secondary	Sleep onset time via self-reported recording in a Sleep Diary	Change from baseline to the end of the study period in Sleep Onset Time via Consensus Sleep Diary (CSD)	Day 0 to 56
Secondary	Sleep pattern via self-reported recording in a Sleep Diary	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)	Day 0 to 56
Secondary	Daytime Sleepiness via the Epworth Sleepiness Scale	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.	Day 0 to 56
Secondary	Stress via the Perceived Stress Scale	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	Day 0 to 56
Secondary	Stress via self reported Profile of Mood States Questionnaire	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	Day 0 to 56
Secondary	Anxiety via self-reported Beck Anxiety Inventory questionnaire	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)	Day 0 to 56
Secondary	Stress via Salivary cortisol test	Change from baseline to the end of the study period in Stress via Salivary cortisol test	Day 0 to 56
Secondary	Alertness via Reaction Time Test	Change from baseline to the end of the study period in Alertness via Reaction Time Test	Day 0 to 56
Secondary	Circadian cycles via melatonin and serotonin via blood test	Change from baseline to the end of the study period in markers associated with circadian cycles - melatonin and serotonin via blood test	Day 0 to 56
Secondary	Markers associated with inflammation via blood test	Change from baseline to the end of the study period in Inflammatory Markers such as CRP, TNF-a and IL-6 via blood test	Day 0 to 56
Secondary	Sleep onset latency via wearable sleep tracker	Change from baseline to the end of the study sleep onset latency measured in minutes using a wearable sleep tracker	Day 0 to 56
Secondary	Total sleep time spent in sleep phases via wearable sleep tracker	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	Day 0 to 56
Secondary	Blood pressure via blood pressure machine	Change from baseline to the end of the study in blood pressure measured in mmHG	Day 0 to 56
Secondary	Heart rate via blood pressure machine	Change from baseline to the end of the study in heart rate measured in beats per minute using a blood pressure machine	Day 0 to 56
Secondary	Body Temperature via wearable sleep tracker	Change from baseline to the end of the study in body temperature measured in Celsius using a wearable sleep tracker	Day 0 to 56
Secondary	BMI via height and weight measurements	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.	Day 0 to 56