Sleep, Sleep Disorder
Conditions
Keywords
Sleep Quality
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.
Interventions
DIETARY_SUPPLEMENTBEAM Dream Powder
A powdered sleep supplement. Administered daily, mixed with 8-12 oz hot water, 30 minutes before bedtime during Weeks 3-6.
DIETARY_SUPPLEMENTPlacebo Control
A powdered placebo product. Administered daily, mixed with 8-12 oz hot water, 30 minutes before bedtime during Weeks 1-2.
Sponsors
Citruslabs
Beam
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 tracker | Baseline, 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
| Measure | Time frame | Description |
|---|---|---|
| Change in emotional well-being as measured by self-reported questionnaire | Baseline, Week 2, Week 4, Week 6 | Emotional well-being will be assessed using a validated self-report measure. |
| Change in perceived restfulness as measured by self-reported questionnaire | Baseline, Week 2, Week 4, Week 6 | Participants will report perceived restfulness levels to assess subjective recovery and rest post-intervention. |
| Change in dietary behavior (e.g., hunger levels) as measured by self-reported questionnaire | Baseline, Week 2, Week 4, Week 6 | Participants will report perceived hunger levels and related dietary behavior using a structured questionnaire. |
| Change in cognitive function as measured by self-reported questionnaire | Baseline, Week 2, Week 4, Week 6 | Cognitive function will be assessed through a participant questionnaire evaluating attention, memory, and mental clarity. |
| Change in overall energy levels as measured by self-reported questionnaire | Baseline, Week 2, Week 4, Week 6 | Participants will rate their energy levels using a structured questionnaire. |
Countries
United States
Outcome results
None listed