Sleep
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBare performance supplement
dietary supplement
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Citruslabs
Bare Performance Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
single-blinded observational randomized-control trial
Eligibility
Sex/Gender
ALL
Age
24 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed