Status:
COMPLETED
Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress
Lead Sponsor:
Asystem, Inc.
Collaborating Sponsors:
Citruslabs
Conditions:
Sleep
Stress
Eligibility:
All Genders
24-45 years
Phase:
NA
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05190640
Start Date
November 1 2021
End Date
March 15 2022
Last Update
April 1 2022
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404