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OpenTrials
Completed

NCT Number: NCT05190640

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

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.

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Key information

Conditions

Sleep Anxiety Anxiety Disorders Mental Disorders Stress

Age range

24 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

De-Stress Gummies

Dietary Supplement

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Asystem, Inc.

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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