Study to Evaluate the Efficacy of Bare Performance Nutrition's Peak Sleep Supplementation on Sleep Quality and Duration.

Not Applicable

Completed

• Conditions: Sleep

• Registration Number: NCT05222919
• Lead Sponsor: Bare Performance Nutrition

Brief Summary

This is a single-blinded observational randomized-control trial to study the efficacy of a dietary supplement and its effect on sleep quality, recovery, and workout performance.

Detailed Description

This is a single-blinded observational randomized-control trial to study the efficacy of a dietary supplement and its effect on sleep quality, recovery, and workout performance.

It is hypothesized that the dietary supplement "Peak Sleep" will improve sleep quality - as defined as deep sleep, REM sleep, and feeling more rested the next day, as well as promoting the performance in workouts of trial participants.

A total of 72 participants will be recruited for the trial following the screening. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants, and participants will either receive the "Peak Sleep" product or receive a placebo - depending on the study group they got randomized in - for eight weeks.

Study Timeline

• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-03
• Study Start: 2022-02-15
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Male & Female between 24-45 years old
• Self-reported mild to moderate sleep issues
• 3+ days of physical exercise per week
• Self-reported stressful lifestyle
• Own a sleep tracker that can be used for the study (e.g. Oura ring, Apple Watch, FitBit, -Whoop band, or similar other devices)
• Must be in good health (don't report any medical conditions asked in the screening questionnaire)
• Following a stable, consistent diet regimen
• Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes

Exclusion Criteria

• Severe chronic conditions including oncological conditions, psychiatric disease, or other
• Diagnosed insomnia
• Food intolerances/allergies that require an EpiPen
• Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
• Individuals that participate in another research study during the study period
• Individuals with a history of drug, alcohol, or substance abuse
• Individuals taking any other sleep supplements and are unwilling to stop taking those supplements for the duration of the study period
• Individuals who have night terrors regularly
• Individuals who regularly sleepwalk
• Individuals who have regular bad dreams

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in sleep quality	Baseline to 8 weeks	Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in sleep quality between baseline and study intervention period.
Change in recovery time after a workout	Baseline to 8 weeks	Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in workout recovery time between baseline and study intervention period.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States