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

NCT05222919 | Completed

• 1 other identifier: 20225
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Bare performance supplement

ACTIVE COMPARATOR

Dietary supplement

Dietary Supplement: Bare performance supplement

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Bare performance supplement DIETARY_SUPPLEMENT

dietary supplement

Bare performance supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male \& Female between 24-45 years old
• Self-reported mild to moderate sleep issues
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bare Performance Nutrition: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Officials

• Susanne Mitschke

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-blinded observational randomized-control trial

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 3, 2022
• Study Start: February 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

US (1)