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

Asystem

Status: Completed

Conditions: Anxiety; Sleep; Stress

Treatments: Dietary Supplement: De-Stress Gummies

Study type: Interventional

Funder types: Industry

Identifiers

NCT05190640

20221Asystem

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 24 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Intervention arm

Experimental group

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.

Treatment:

Dietary Supplement: De-Stress Gummies