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

Primary Purpose

Sleep, Stress, Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

De-Stress Gummies

About this trial

This is an interventional other trial for Sleep

Eligibility Criteria

24 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05190640

First Posted

December 31, 2021

Last Updated

March 30, 2022

Sponsor

Asystem, Inc.

Collaborators

Citruslabs

1. Study Identification

Unique Protocol Identification Number

NCT05190640

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

March 15, 2022 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asystem, Inc.

Collaborators

Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep, Stress, Anxiety

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

De-Stress Gummies

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in sleep quality [Time Frame: Baseline to 4 weeks)

Description

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.

Time Frame

4 weeks

Title

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

Description

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.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne Mitschke, MSc

Organizational Affiliation

Citruslabs

Official's Role

Principal Investigator

Facility Information:

Facility Name

Citruslabs

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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