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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| De-Stress Gummies | Dietary Supplement | one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke, MSc | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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