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A Crossover Trial to Examine the Efficacy of a Powder to Improve Sleep Quality and Performance

Not Applicable
Completed
Conditions
Sleep
Sleep Disorder
Registration Number
NCT07183735
Lead Sponsor
Beam
Brief Summary

This is a randomized, placebo-controlled crossover study to assess the efficacy of BEAM's Dream Powder in improving sleep health among 40 adults. Participants will use a placebo for 2 weeks, followed by the test product for 4 weeks, with sleep data collected via questionnaires and a Fitbit sleep tracker.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Male or female
  • 18+ years old
  • Self-reported issues with sleeping, falling asleep, or staying asleep.
  • Willing to discontinue any supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the study duration.
  • Willing to avoid introducing any other supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of this trial.
  • Willing to maintain their standard sleep pattern and activity level for the duration of the study.
  • Be generally healthy and not live with any uncontrolled chronic disease.
Exclusion Criteria
  • Diagnosed with any chronic sleep condition, including but not limited to insomnia, narcolepsy, or sleep apnea.
  • Women who are pregnant, breastfeeding, or trying to conceive.
  • Anyone unwilling or unable to follow the study protocol.
  • Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Is currently undergoing, or planning to undergo, any significant medical procedures during the study period.
  • Has undergone any surgeries or invasive treatments in the last six months.
  • A history of severe allergic reactions, including but not limited to any of the product's ingredients.
  • Anyone with a nut allergy.
  • Heavy drinkers. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.
  • Anyone who uses illicit drugs.
  • Use any prescription medication, over-the-counter, or herbal remedies that can affect sleep.
  • Have a job that involves working the third or night shifts.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Change in sleep quality as measured by the Sleep Quality Scale (SQS)Baseline, Week 2, Week 4, Week 6

Sleep quality will be assessed using the self-reported Sleep Quality Scale (SQS), a validated questionnaire evaluating subjective sleep quality.

Change in sleep quantity and architecture as measured by sleep trackerBaseline, Week 2, Week 4, Week 6

Objective sleep metrics (e.g., time to fall asleep, deep sleep, REM sleep, sleep transitions, sleep duration, and frequency of waking) will be collected using a sleep tracking device.

Secondary Outcome Measures
NameTimeMethod
Change in perceived restfulness as measured by self-reported questionnaireBaseline, Week 2, Week 4, Week 6

Participants will report perceived restfulness levels to assess subjective recovery and rest post-intervention.

Change in overall energy levels as measured by self-reported questionnaireBaseline, Week 2, Week 4, Week 6

Participants will rate their energy levels using a structured questionnaire.

Change in emotional well-being as measured by self-reported questionnaireBaseline, Week 2, Week 4, Week 6

Emotional well-being will be assessed using a validated self-report measure.

Change in cognitive function as measured by self-reported questionnaireBaseline, Week 2, Week 4, Week 6

Cognitive function will be assessed through a participant questionnaire evaluating attention, memory, and mental clarity.

Change in dietary behavior (e.g., hunger levels) as measured by self-reported questionnaireBaseline, Week 2, Week 4, Week 6

Participants will report perceived hunger levels and related dietary behavior using a structured questionnaire.

Trial Locations

Locations (1)

Citruslabs

🇺🇸

Las Vegas, Nevada, United States

Citruslabs
🇺🇸Las Vegas, Nevada, United States

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