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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Bare performance supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blinded observational randomized-control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bare performance supplement<br>Dietary supplement | Dietary Supplement: Bare performance supplement<br>* dietary supplement<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality | 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. | Baseline to 8 weeks | 
| Change in recovery time after a workout | 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. | Baseline to 8 weeks |