Study to Evaluate the Efficacy of Bare Performance Nutrit... | NCT05222919

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

NCT05222919

Sponsor

Bare Performance Nutrition

Status

Completed

Last Update Posted

Jun 21, 2022Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Sleep

Interventions

Bare performance supplement
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Apr 15, 2022Actual

Completion Date

Apr 15, 2022Actual

First Submitted Date

Jan 25, 2022

First Submission Date that Met QC Criteria

Feb 2, 2022

First Posted Date

Feb 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2022

Last Update Posted Date

Jun 21, 2022Actual

Name	Class
Citruslabs	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bare performance supplement	Active Comparator	Dietary supplement	Dietary Supplement: Bare performance supplement
Placebo	Placebo Comparator	Placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bare performance supplement	Dietary Supplement	dietary supplement	Bare performance supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Susanne Mitschke	Citruslabs	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Citruslabs		Santa Monica	California	90404	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided