An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity

Sleep Clinical Trial

Official title:

An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521243
• Other study ID #: 20241
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Beam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep
• Sleep Disturbance
• Sleep Hygiene

Intervention

Dietary Supplement:
• Beam Organics Dream Powder
The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern
• Beam Organics Dream Powder Extra Strength
The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern
• Placebo
The main ingredients in the placebo are: Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Beam	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Weeks
Primary	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.	6 weeks
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	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.	6 Weeks