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

Not Applicable

Completed

• Conditions: Sleep Hygiene; Sleep; Sleep Disturbance
• Interventions: Dietary Supplement: Beam Organics Dream Powder; Dietary Supplement: Beam Organics Dream Powder Extra Strength; Dietary Supplement: Placebo

• Registration Number: NCT05521243
• Lead Sponsor: Beam

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo + Dream Powder	Placebo	Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks.
Placebo + Dream Powder	Beam Organics Dream Powder	Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks.
Placebo + Dream Powder Extra Strength	Beam Organics Dream Powder Extra Strength	Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks.
Placebo + Dream Powder Extra Strength	Placebo	Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks.

Primary Outcome Measures

Name	Time	Method
Perceived Changes in Sleep Quality as reported by questionnaires	6 Weeks	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	6 weeks	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	6 weeks	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	6 weeks	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

Name	Time	Method
Examine changes in device measured sleep across the six week trial.	6 Weeks	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States