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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190640
• Other study ID #: 20221Asystem
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Asystem, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Sleep
• Stress

Intervention

Dietary Supplement:
• De-Stress Gummies
one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Asystem, Inc.	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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