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

Sponsor

Asystem, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05190640

Collaborator

Citruslabs (Other)

Enrollment

Location

Arm

4.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Stress Anxiety	Dietary Supplement: De-Stress Gummies	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Mar 15, 2022

Actual Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 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 one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies

Arm

Intervention/Treatment

Experimental: Intervention arm

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

one gummy a day for De-Stress Gummies and one gummy a day for Sleep Gummies

Outcome Measures

Primary Outcome Measures

Change in sleep quality [Time Frame: Baseline to 4 weeks) [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.
Change in stress and anxiety [Time Frame: Baseline to 4 weeks) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

Asystem, Inc.
Citruslabs

Investigators

Principal Investigator: Susanne Mitschke, MSc, Citruslabs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asystem, Inc.

ClinicalTrials.gov Identifier:

NCT05190640

Other Study ID Numbers:

20221Asystem

First Posted:

Jan 13, 2022

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Apr 1, 2022