Back to resultsAn Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
Primary Purpose
Sleep, Sleep Disturbance, Sleep Hygiene
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beam Organics Dream Powder
Beam Organics Dream Powder Extra Strength
Placebo
Sponsored by
About this trial
This is an interventional other trial for Sleep focused on measuring Sleep, Sleep Disturbance, Sleep Quality, Sleep Quantity
Eligibility Criteria
Inclusion Criteria:
- Self-reported issues with sleep Must be in good overall health with no unstable medical conditions Must own a wearable sleep tracker (i.e., Apple Watch, "FitBit", "Whoop", etc.) Must be willing to discontinue any supplements meant to assist with sleep.
Exclusion Criteria:
- Females who are pregnant or breastfeeding Diagnosis of insomnia or sleep apnea Taking a prescription medication that affects sleep Anyone with a pre-existing condition that would prevent them from adhering to the protocol Anyone with a known history of past severe allergic reactions
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo + Dream Powder
Placebo + Dream Powder Extra Strength
Arm Description
Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks.
Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks.
Outcomes
Primary Outcome Measures
Perceived Changes in Sleep Quality as reported by questionnaires
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Perceived Changes in Sleep Quantity as reported by questionnaires
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Perceived Changes in Sleep Habits as reported by Questionnaires
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Participant Perceptions of Sleep
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Secondary Outcome Measures
Examine changes in device measured sleep across the six week trial.
Sleep will be measured with fitness trackers to provide an objective outcome measure of sleep across the six week trial. Both sleep time and sleep quality will be examined. Participants will report their sleep data from the previous week at Baseline, Week 2, Week 4, and Week 6.
Full Information
NCT ID
NCT05521243
First Posted
August 24, 2022
Last Updated
November 7, 2022
Sponsor
Beam
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05521243
Brief Title
An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
Official Title
An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beam
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra Strength over a six week period. The main outcomes of interest will be sleep quantity and quality, as well as self-reported changes in sleep across the study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Disturbance, Sleep Hygiene
Keywords
Sleep, Sleep Disturbance, Sleep Quality, Sleep Quantity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + Dream Powder
Arm Type
Experimental
Arm Description
Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks.
Arm Title
Placebo + Dream Powder Extra Strength
Arm Type
Experimental
Arm Description
Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beam Organics Dream Powder
Intervention Description
The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern
Intervention Type
Dietary Supplement
Intervention Name(s)
Beam Organics Dream Powder Extra Strength
Intervention Description
The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The main ingredients in the placebo are:
Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor
Primary Outcome Measure Information:
Title
Perceived Changes in Sleep Quality as reported by questionnaires
Description
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Time Frame
6 Weeks
Title
Perceived Changes in Sleep Quantity as reported by questionnaires
Description
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Time Frame
6 weeks
Title
Perceived Changes in Sleep Habits as reported by Questionnaires
Description
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Time Frame
6 weeks
Title
Participant Perceptions of Sleep
Description
Examined across the six week trial with questionnaires. These questionnaires will occur at Baseline, Week 2, Week 4, and Week 6, and will gather information about their ability to fall asleep, stay asleep, and the overall amount of sleep they get on average during the past week.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Examine changes in device measured sleep across the six week trial.
Description
Sleep will be measured with fitness trackers to provide an objective outcome measure of sleep across the six week trial. Both sleep time and sleep quality will be examined. Participants will report their sleep data from the previous week at Baseline, Week 2, Week 4, and Week 6.
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-reported issues with sleep Must be in good overall health with no unstable medical conditions Must own a wearable sleep tracker (i.e., Apple Watch, "FitBit", "Whoop", etc.) Must be willing to discontinue any supplements meant to assist with sleep.
Exclusion Criteria:
Females who are pregnant or breastfeeding Diagnosis of insomnia or sleep apnea Taking a prescription medication that affects sleep Anyone with a pre-existing condition that would prevent them from adhering to the protocol Anyone with a known history of past severe allergic reactions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill, PhD
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
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