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

NCT ID: NCT05521243

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2022-09-30

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.

Conditions

Sleep; Sleep Disturbance; Sleep Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo + Dream Powder

Participants take the placebo product for two weeks, followed by the Dream Powder intervention product for four weeks.

Group Type: EXPERIMENTAL

Beam Organics Dream Powder

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

The main ingredients in the placebo are:

Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor

Placebo + Dream Powder Extra Strength

Participants take the placebo product for two weeks, followed by the Dream Powder Extra Strength intervention product for four weeks.

Group Type: EXPERIMENTAL

Beam Organics Dream Powder Extra Strength

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

The main ingredients in the placebo are:

Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The main ingredients in the placebo are:

Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Beam

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20241

Identifier Type: -

Identifier Source: org_study_id