Effects of PeptiSleep on Sleep Quality in Healthy Adults

Nuritas

Status: Enrolling

Conditions: Healthy Participants; Wearable Technology; Cognitive Abilities; Cortisol; Sleep

Treatments: Dietary Supplement: PeptiSleep; Dietary Supplement: Micro-crystalline cellulose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07258433

PEPSLE2

Details and patient eligibility

About

Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.
• 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

Exclusion criteria

• 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.
• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

PeptiSleep 250 mg/day

Experimental group

Description:

One capsule to be consumed orally 30-60 minutes before bed

Treatment:

Dietary Supplement: PeptiSleep

Microcrystalline Cellulose 250 mg/day

Placebo Comparator group

Description:

One capsule to be consumed orally 30-60 minutes before bed

Treatment:

Dietary Supplement: Micro-crystalline cellulose