120 Participants Needed

PeptiSleep for Sleep

NM
Overseen ByNiamh M Mohan, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively PeptiSleep, a plant-based sleep aid, improves sleep quality in healthy adults. Participants will take either PeptiSleep or a placebo (a pill with no active ingredients) before bed to compare the effects. Individuals who are generally healthy, maintain a stable lifestyle, and do not currently use sleep medications are ideal candidates for this study. As an unphased trial, it offers participants the chance to contribute to research on natural sleep aids.

Is there any evidence suggesting that PeptiSleep is likely to be safe for humans?

Research shows that PeptiSleep, a plant-based sleep aid, has undergone safety testing in humans. In earlier studies, researchers examined any unwanted side effects reported by participants. These studies aimed to assess tolerance to PeptiSleep and determine the optimal dose for improving sleep.

Another study focused on healthy adults, evaluating how PeptiSleep affected their sleep quality while also monitoring its safety. Results from these studies provide a clearer understanding of PeptiSleep's safety. However, as research continues, participants should be aware that not all possible side effects are fully known yet.12345

Why do researchers think this study treatment might be promising?

PeptiSleep is unique because it introduces a novel approach to improving sleep by utilizing a peptide-based formula. Unlike many existing sleep aids, which often rely on sedative effects or altering neurotransmitter levels, PeptiSleep is designed to work with the body's natural sleep mechanisms. Researchers are excited about PeptiSleep's potential for fewer side effects and a more natural sleep cycle restoration, offering a promising alternative to traditional sleeping pills.

What evidence suggests that PeptiSleep might be an effective treatment for sleep?

Research has shown that PeptiSleep, a plant-based sleep aid, may improve sleep quality. Studies have found that it helps people spend more time in deep, restful sleep. One study found that PeptiSleep can help individuals fall asleep faster. Devices used in the trials confirmed these benefits, showing real improvements in sleep patterns. These early results suggest that PeptiSleep could be a good option for those seeking better sleep. Participants in this trial will receive either PeptiSleep or a placebo to further evaluate its effectiveness.13678

Who Is on the Research Team?

MD

Mackenzie De Jesus, DHSc, MS

Principal Investigator

Reputable Health

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 with a BMI of 18.5 - 35.0kg/m2 who are willing to take a capsule daily, wear a sleep tracker, and complete surveys and cognitive tests. Participants must maintain their current diet, exercise, lifestyle, and medication routines without changes.

Inclusion Criteria

I am between 18 and 65 years old.
I am generally in good health.
My BMI is between 18.5 and 35.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants wear a sleep tracker for 4 weeks to collect baseline sleep data

4 weeks
No in-person visits, data collected remotely

Treatment

Participants receive PeptiSleep or placebo for 6 weeks, with sleep quality and cognitive performance assessed

6 weeks
No in-person visits, data collected remotely

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PeptiSleep

Trial Overview

The study is testing PeptiSleep, a plant-based sleep aid versus an inactive substance (placebo), to see if it improves sleep quality in healthy adults using fitness trackers and cognitive assessments over six weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PeptiSleep 250 mg/dayExperimental Treatment1 Intervention
Group II: Microcrystalline Cellulose 250 mg/dayPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nuritas Ltd

Lead Sponsor

Trials
7
Recruited
400+

Reputable Health

Collaborator

Citations

Effects of PeptiSleep in Healthy Males and Females With ...

Secondary endpoints investigated during the trial will include changes sleep quantity and quality, insomnia severity, daytime sleepiness, stress and anxiety ...

Effects of PeptiSleep 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.

Effects of PeptiSleep in Healthy Males and Females With ...

Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1299794/

Effects of delta sleep-inducing peptide on sleep of chronic ...

The results for objective sleep quality indicated higher sleep efficiency and shorter sleep latency with DSIP as compared to placebo. One measure of ...

How Wearables Like Oura Are Revolutionizing Clinical Trials

Wearable enabled validation allows Nuritas to substantiate PeptiSleep's benefits through objective metrics: improvements in sleep efficiency, ...

Effects of PeptiSleep in Healthy Males and Females with Mild ...

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 ...

Effects of PeptiSleep on Sleep Quality in Healthy Adults

Adults aged 18-65 at the time of enrollment. - Generally healthy - BMI 18.5 - 35.0kg/m2 - Willing and able to provide informed consent.

PEPSLE Screening

The aim of this study is to assess the safety and effective dose of a plant-based sleep aid, PeptiSleep in healthy males and females with mild to moderate ...