SleepNCT07258433
Effects of PeptiSleep on Sleep Quality in Healthy Adults
A study testing PeptiSleep and Micro-crystalline cellulose in people with Sleep and Wearable Technology, run by Nuritas Ltd at 1 site in United States.
Trial summary
Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Wearable Technology, Cortisol
- What is being tested?
- PeptiSleep and Micro-crystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2025to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 at the time of enrollment.
- Generally healthy
- BMI 18.5 - 35.0kg/m2
- Willing and able to provide informed consent.
- Willing to consume one PeptiSleep or placebo capsule daily for 6 weeks.
- Willing to wear a sleep tracker continuously throughout the study period.
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- Willing to complete all scheduled surveys and cognitive assessments on Days 0, 1, 2, and 3, at biweekly check-ins (Week 2 and Week 4), and at End-of-Study (Day 42).
- Willing to sync their wearable device data through the Reputable Health app and complete daily check-ins for compliance assessment
- Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
- Agree to maintain a stable lifestyle and medication routines for at least 4 weeks prior to enrollment
- Agree not to use other medicines or supplements for sleep, stress, depression, or anxiety other than the test product during enrolment period.
- Agree to refrain from participation in another clinical trial during enrolment period.
- Agree to comply with Creyos digital platform data usage and privacy policy
Who cannot join
- Are currently pregnant, breastfeeding, or planning pregnancy during the study period.
- Are using prescription or over-the-counter sleep medications (e.g., zolpidem, melatonin >5 mg, benzodiazepines, CBD or antihistamines used for sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
- Have a current diagnosis of a chronic medical condition or illness (e.g., uncontrolled thyroid disease, diabetes, cardiovascular disease, major depressive disorder, or anxiety disorder requiring ongoing pharmacologic treatment) or a chronic sleep disorder, insomnia, restless leg syndrome, sleep apnoea.
- Are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 4-weeks and any other sleep clinical trial during the past 3 months.
- Have a known allergy or sensitivity to any component of the investigational or placebo product
- Are shift workers or have highly irregular sleep/wake schedules that could confound study outcomes.
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- Are unable or unwilling to comply with daily product use, wearable requirements, or survey/assessment completion.
- Have with significant non-wear time of their Oura device exceeding a 48- hour period
- Are using medications which induce CYP3A4 such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids.
- Are using prescription or OTC medications or supplements for sleep, stress, depression, or anxiety including CBD within one month prior to enrolment.
- Are using aromatherapy to help manage sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
- Are using a digital device (besides Oura) to help monitor or manage sleep during the study period.
- Have a current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- Have been diagnosed with or have consistent gastrointestinal issues that disrupt sleep.
- Have a history of renal function impairment
- Have with COPD or a chronic breathing disorder
- Are active smokers, nicotine use or drug (prescription or illegal substances) abuse.
- Have a chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Are regularly taking stimulants (e.g., coffee, caffeine supplements, beverages containing caffeine) 5 hours before bed
- Are regularly consuming more than 500mg of caffeine per day
- Have any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 6-Week Decentralised Trial Evaluating the Effects of PeptiSleep on Sleep Quality in Healthy Adults
Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults
Read the detailed description
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.
- Conditions
- Sleep, Wearable Technology, Cortisol, Healthy Participants, Cognitive Abilities
- Being tested
- PeptiSleep, Micro-crystalline cellulose
- Keywords
- Sleep, Decentralised Study, Peptide Therapeutics, Protein Hydrolysates, Sleep Quality, Leeds Sleep Evaluation Questionnaire, Creyos, Oura, Wearable Technology
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeptiSleepDietary supplement
Rice Protein Hydrolysate
Micro-crystalline celluloseDietary supplement
Placebo MCC micro-crystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| PeptiSleep 250 mg/day | Experimental | One capsule to be consumed orally 30-60 minutes before bed Receives: Dietary Supplement: PeptiSleep |
| Microcrystalline Cellulose 250 mg/day | Placebo comparator | One capsule to be consumed orally 30-60 minutes before bed Receives: Dietary Supplement: Micro-crystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 to Day 42
Secondary outcomes (12)
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:
- Subjective Sleep Quality
- Sleep Latency
- Sleep Duration
- Habitual Sleep Efficiency
- Sleep Disturbances
- Use of Sleeping Medication
- Daytime Dysfunction
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 0 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start29 Dec 2025
- Primary completion28 Feb 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Decentralised, Double-Blind, Placebo-Controlled, Parallel-Design study conducted over 6-weeks
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reputable Health
- Responsible party
- Sponsor
- Investigators
- Mackenzie De Jesus, DHSc, MS, Principal investigator, Reputable Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258433
- Sponsor's protocol ID
- PEPSLE2
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 6-Week Decentralised Trial Evaluating the Effects of PeptiSleep on Sleep Quality in Healthy Adults
- ClinicalTrials.gov ID
- NCT07258433
- Acronym / sponsor ID
- PEPSLE2
- Conditions
- Sleep, Wearable Technology, Cortisol, Healthy Participants, Cognitive Abilities
- Keywords
- Sleep, Decentralised Study, Peptide Therapeutics, Protein Hydrolysates, Sleep Quality, Leeds Sleep Evaluation Questionnaire, Creyos, Oura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Collaborators
- Reputable Health
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Decentralised, Double-Blind, Placebo-Controlled, Parallel-Design study conducted over 6-weeks
| Arm | Type | Receives |
|---|---|---|
| PeptiSleep 250 mg/day | Experimental | Dietary Supplement: PeptiSleepOne capsule to be consumed orally 30-60 minutes before bed |
| Microcrystalline Cellulose 250 mg/day | Placebo comparator | Dietary Supplement: Micro-crystalline celluloseOne capsule to be consumed orally 30-60 minutes before bed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 18-65 at the time of enrollment.
- Generally healthy
- BMI 18.5 - 35.0kg/m2
- Willing and able to provide informed consent.
- Willing to consume one PeptiSleep or placebo capsule daily for 6 weeks.
Key exclusion criteria (21 listed)
- Are currently pregnant, breastfeeding, or planning pregnancy during the study period.
- Are using prescription or over-the-counter sleep medications (e.g., zolpidem, melatonin >5 mg, benzodiazepines, CBD or antihistamines used for sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
- Have a current diagnosis of a chronic medical condition or illness (e.g., uncontrolled thyroid disease, diabetes, cardiovascular disease, major depressive disorder, or anxiety disorder requiring ongoing pharmacologic treatment) or a chronic sleep disorder, insomnia, restless leg syndrome, sleep apnoea.
- Are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 4-weeks and any other sleep clinical trial during the past 3 months.
- Have a known allergy or sensitivity to any component of the investigational or placebo product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeptiSleepRice Protein Hydrolysate | Dietary supplement | PeptiSleep 250 mg/day |
| Micro-crystalline cellulosePlacebo MCC micro-crystalline cellulose | Dietary supplement | Microcrystalline Cellulose 250 mg/day |
Primary outcome
Sleep Quality via Leeds Sleep Evaluation Questionnaire
Time frame: Day 0 to Day 42
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
12 secondary outcomes
Sleep Quality via Pittsburgh Sleep Quality Index
Time frame: Day 0 to Day 42
Heart Rate Variability via Wearable Technology
Time frame: Day 0 to Day 42
Nocturnal Heart Rate via Wearable Technology
Time frame: Day 0 to Day 42
Sleep Onset Latency via Wearable Technology
Time frame: Day 0 to Day 42
Sleep Architecture via Wearable Technology
Time frame: Day 0 to Day 42
Sleep Summary Metrics via Wearable Technology
Time frame: Day 0 to Day 42
Safety and Tolerability via Adverse Event Reporting
Time frame: Day 0 to Day 42
Feature Match Attention Test
Time frame: Day 0 to Day 42
Double Trouble Accuracy Test
Time frame: Day 0 to Day 42
Token Search Memory Test
Time frame: Day 0 to Day 42
Visuospatial Reasoning via Number Ladder Test
Time frame: Day 0 to Day 42
Verbal Short Term Memory via Digit Span Test
Time frame: Day 0 to Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mackenzie De Jesus, DHSc, MS principal investigator
Reputable Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeptiSleep and Micro-crystalline cellulose in people with Sleep and Wearable Technology, run by Nuritas Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality via Leeds Sleep Evaluation Questionnaire (time frame: Day 0 to Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.