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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222919
• Other study ID #: 20225
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: April 15, 2022

Study information

• Verified date: June 2022
• Source: Bare Performance Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Bare performance supplement
dietary supplement
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Bare Performance Nutrition	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep quality	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.	Baseline to 8 weeks
Primary	Change in recovery time after a workout	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.	Baseline to 8 weeks