Clinical trial NCT05222919: Study to Evaluate the Efficacy of Bare Performance Nutrition's Peak Sleep Supplementation on Sleep Quality and Duration.
Official title: Study to Evaluate the Efficacy of Bare Performance Nutrition's Peak Sleep Supplementation on Sleep Quality and Duration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Bare Performance Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-02-03
Enrollment: 72
Sex: ALL
Minimum age (years): 24
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded observational randomized-control trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sleep quality
timeFrame: Baseline to 8 weeks
measure: Change in recovery time after a workout
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke
role: PRINCIPAL_INVESTIGATOR
References: