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

B

Bare Performance Nutrition

Status

Completed

Conditions

Sleep

Treatments

Dietary Supplement: Bare performance supplement
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

24 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups, including a placebo group

Bare performance supplement
Active Comparator group
Description:
Dietary supplement
Treatment:
Dietary Supplement: Bare performance supplement
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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