Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress

Study Overview
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Brief Summary
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This is an open-label observational single-arm clinical trial to study the efficacy of a commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood, and stress.

Detailed Description
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It is hypothesized that the dietary supplement marketed as Asystems Complete Calm (consisting of De-Stress Gummies and Sleep Gummies) will improve subjective wellbeing in trial participants, through promoting restful sleep (looking at sleep quality and duration), and reducing stress and anxiety, while lifting up the participants' mood. A total of 35 participants will be recruited for the trial following the screening. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants, and all participants will take the Complete Calm Product, consisting of the De-Stress Gummies (day) and Sleep Gummies (night) for four weeks.

Official Title
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Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress

Conditions
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Sleep, Stress, Anxiety

Intervention / Treatment
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* Dietary Supplement: De-Stress Gummies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male & Female between 24-45 years old Self-reported (undiagnosed) mild to moderate sleep issues Self-reported (undiagnosed) mild to moderate anxiety Self-reported stressful lifestyle Must be in good health (don't report any medical conditions asked in the screening questionnaire) Following a stable, consistent diet regimen Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes Exclusion Criteria: Currently taking any prescription anti-depressants Currently receiving other psychotherapeutic treatment for anxiety or depression Severe chronic conditions including oncological conditions, psychiatric disease, or other Diagnosed insomnia Diagnosed anxiety or depression Food intolerances/allergies that require an epipen Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>The dietary supplement (Asystems) is designed, and marketed commercially to be taken in servings of one gummy: one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies. | Dietary Supplement: De-Stress Gummies<br>* one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality [Time Frame: Baseline to 4 weeks) | Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in sleep quality between baseline and study intervention period. | 4 weeks | 
| Change in stress and anxiety [Time Frame: Baseline to 4 weeks) | Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in stress/anxiety between baseline and study intervention period. | 4 weeks |