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| Name | Class |
|---|---|
| Reputable Health | OTHER |
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Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults
The primary aim of this is double-blind placebo-controlled parallel-design study is to measure the effects of PeptiSleep on sleep quality in healthy adults. PeptiSleep will be supplemented 30-60 minutes before bed as a single oral dose of 250mg for 6-weeks. A placebo group will also be included who will receive a matched dose of microcrystalline cellulose in identical capsules.
This trial incorporates a wearable sleep tracker to measure sleep biometrics which will be worn by participants for the duration of the study, as well as clinically validated questionnaires to measure sleep quality and a digital cognitive battery for to assess next day performance. The trial will be conducted over 6-weeks. 4 weeks of sleep tracking data will serve as a baseline prior to initiation of the supplementation period. The trial is fully decentralised.
The primary endpoint will measure the effects of PeptiSleep supplementation on responsive sleep quality via Leeds Sleep Evaluation Questionnaire versus a placebo from baseline to the end of the study period.
Secondary endpoints investigated during the trial will include changes in sleep biometrics (cardiac measures, sleep architecture, latency etc.) via Oura wearable, changes in comprehensive sleep quantity via Pittsburgh Sleep Quality Index (PSQI), next day readiness and next day performance via Creyos digital testing platform and safety and tolerability via adverse event reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PeptiSleep 250 mg/day | Experimental | One capsule to be consumed orally 30-60 minutes before bed |
|
| Microcrystalline Cellulose 250 mg/day | Placebo Comparator | One capsule to be consumed orally 30-60 minutes before bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PeptiSleep | Dietary Supplement | Rice Protein Hydrolysate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 0 to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality via Pittsburgh Sleep Quality Index | Change from baseline to the end of the study period in Sleep Quality via the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a standardised self-rated questionnaire that assesses sleep quality and disturbances over a 1-month interval. It consists of 19 individual items, which generate seven component scores that reflect key aspects of sleep. Each component is scored on a scale from 0 to 3, where lower scores indicate no difficulty and higher scores indicate increasing difficulty. The seven component scores are summed to yield a global score ranging from 0 to 21, with higher global scores representing poorer overall sleep quality. The seven PSQI components are as follows:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mackenzie De Jesus, DHSc, MS | Reputable Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reputable Labs Inc. | Wilmington | Delaware | 19808 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Randomized, Decentralised, Double-Blind, Placebo-Controlled, Parallel-Design study conducted over 6-weeks
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| Micro-crystalline cellulose |
| Dietary Supplement |
Placebo MCC micro-crystalline cellulose |
|
| Day 0 to Day 42 |
| Heart Rate Variability via Wearable Technology | Change from baseline to the end of the study in heart Rate variability recorded as the time interval between two heartbeats in milliseconds between groups | Day 0 to Day 42 |
| Nocturnal Heart Rate via Wearable Technology | Change from baseline to the end of the study in the number of heart beats per minute while at rest and asleep between groups | Day 0 to Day 42 |
| Sleep Onset Latency via Wearable Technology | Change from baseline to the end of the study in sleep onset latency measured in minutes between groups | Day 0 to Day 42 |
| Sleep Architecture via Wearable Technology | Change from baseline to the end of the study in time spent in light, deep and REM phases of sleep between groups | Day 0 to Day 42 |
| Sleep Summary Metrics via Wearable Technology | Change from baseline to the end of the study in percentage Sleep score and Readiness scores between groups from 0-100 where 85 or higher is optimal, 70-84 is good and Under 70 is poor. | Day 0 to Day 42 |
| Safety and Tolerability via Adverse Event Reporting | Change from baseline to the end of the study period in safety and tolerability measured as the incidence ratio of adverse event reported between placebo and PeptiSleep | Day 0 to Day 42 |
| Feature Match Attention Test | Change from baseline to the end of the study period in attention between groups measured via feature match test on the Creyos cognitive digital platform. The test measured the number of correct matches within 90 seconds. Higher scores indicate better attention | Day 0 to Day 42 |
| Double Trouble Accuracy Test | Change from baseline to the end of the study period in accuracy and response time between groups via double trouble test on the Creyos cognitive digital platform. The test is scored by speed and accuracy in correctly identifying the colour of a word whilst ignoring the words meaning. Higher scored indicate better accuracy. | Day 0 to Day 42 |
| Token Search Memory Test | Change from baseline to the end of the study period in memory and cognitive performance between groups via token search Creyos cognitive digital test. The task score is determined by the maximum level completed and the users ability to solve a puzzle correctly without finding errors. Higher scores indicate better working memory and strategic ability | Day 0 to Day 42 |
| Visuospatial Reasoning via Number Ladder Test | Change from baseline to the end of the study period in visuospatial reasoning and cognitive performance between groups via the number ladder test on Creyos cognitive digital platform. The task score is based on the average number of boxes correctly remembered where higher scores indicate better visual memory. | Day 0 to Day 42 |
| Verbal Short Term Memory via Digit Span Test | Change from baseline to the end of the study period in verbal short term memory and cognitive performance between groups via digit span test on the Creyos cognitive digital platform. The score is calculated based on the longest sequence of digits correctly repeated, whereby higher scores indicate better verbal short term memory. | Day 0 to Day 42 |
| D001523 |
| Mental Disorders |