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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-04-15

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.

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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.

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-blinded observational randomized-control trial

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Bare performance supplement

Dietary supplement

Group Type ACTIVE_COMPARATOR

Bare performance supplement

Intervention Type DIETARY_SUPPLEMENT

dietary supplement

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Bare performance supplement

dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

24 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes