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OpenTrials
Completed

NCT Number: NCT05222919

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

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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Key information

Conditions

Age range

24 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bare performance supplement

Dietary Supplement

dietary supplement

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Change in sleep quality

    Time frame: 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.

  2. Change in recovery time after a workout

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bare Performance Nutrition

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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