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

Launched by NURITAS LTD · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a plant-based sleep aid called PeptiSleep on healthy men and women who have mild to moderate sleep problems. The goal is to see if this product can help improve their sleep quality. To participate, you need to be between 18 and 65 years old, generally healthy, and have a body mass index (BMI) between 18.5 and 33.0. You also need to score low on a sleep questionnaire and have an average sleep score that indicates you’re experiencing some sleep issues. Participants will wear a sleep tracker to monitor their sleep patterns during the study.

If you're interested in joining, you’ll need to be willing to stick to your regular diet and exercise routine and not use any other sleep aids or supplements during the trial. It’s important to note that individuals with serious sleep disorders, certain health conditions, or those currently taking specific medications won't be eligible. Throughout the study, participants can expect to receive the PeptiSleep product and wear the sleep tracker to help the researchers gather data on its effectiveness.

Gender

ALL

Eligibility criteria

• 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.