Share
Save
Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment
Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-08
Primary completion: 2024-12-30
Study completion finish: 2025-02-20
Study type
OTHER
Phase
NA
Trial ID
NCT06267586
Intervention or treatment
DIETARY_SUPPLEMENT: PeptiSleep
DIETARY_SUPPLEMENT: Placebo MCC micro-crystalline cellulose
Conditions
- • Sleep
Find a site
Closest Location:
RDC Clinical
Research sites nearby
Select from list below to view details:
RDC Clinical
Brisbane, Fortitude Valley Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: PeptiSleep 250 mg/day
| DIETARY_SUPPLEMENT: PeptiSleep
|
EXPERIMENTAL: PeptiSleep 500 mg/day
| DIETARY_SUPPLEMENT: PeptiSleep
|
EXPERIMENTAL: PeptiSleep 1000 mg/day
| DIETARY_SUPPLEMENT: PeptiSleep
|
PLACEBO_COMPARATOR: Microcrystalline Cellulose 500mg/day
| DIETARY_SUPPLEMENT: Placebo MCC micro-crystalline cellulose
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Markers associated with inflammation via blood test | Change from baseline to the end of the study period in Inflammatory Markers such as CRP, TNF-α and IL-6 via blood test | Day 0 to 56 |
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 |
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 |
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 |
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 |
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 |
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 |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!