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

NCT05190640 | Completed

• 1 other identifier: 20221Asystem
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Stress; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Dietary Supplement: De-Stress Gummies

Interventions

De-Stress Gummies DIETARY_SUPPLEMENT

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

Intervention arm

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asystem, Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Susanne Mitschke, MSc

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 13, 2022
• Study Start: November 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)