Actively Recruiting

Phase Not Applicable
Age: 22Years - 59Years
All Genders
Healthy Volunteers
ID07311434

Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled Consumer Perception Study on Sleep Supplement Effects

Led by Athletic Greens International · Updated on 2026-02-11

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, randomized, controlled clinical study to evaluate perceived outcomes related to sleep, relaxation, stress, and daytime sleepiness. The study aims to compare the effects of a powdered sleep supplement against participants' usual diet over a 30-day period. Participants will complete questionnaires at specific times to assess their experiences of evening relaxation, sleep quality, and morning vitality. Participants will be randomly assigned to one of two groups: one receiving the powdered sleep supplement and the other maintaining their usual diet without intervention. The treatment period lasts 30 days, during which participants will follow study instructions and limit certain substances like caffeine and alcohol near bedtime. The study does not involve any masking or blinding, and healthy volunteers between 25 and 59 years old are eligible. During the study, participants will complete questionnaires on days 1, 3, 7, 14, and 30 to measure evening relaxation, sleep quality, and morning vitality. Researchers will monitor adherence to the protocol, including restrictions on other supplements, medications, and lifestyle habits that may affect sleep. The total participation time is 30 days, with no additional extension or follow-up periods described.

CONDITIONS

Brief Title

Sleep and Morning Wellbeing Study

Who Can Participate

Age: 22Years - 59Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female.
  • Age 25-59 years.
  • BMI between 18.5 and 29.9 kg/m².
  • Currently experiencing issues with sleep quality, falling asleep, staying asleep, or waking during the night.
  • RU-SATED score of 17 or lower.
  • Willing and able to follow the study protocol.
  • Willing to stop using other supplements, medications, herbal remedies, or over-the-counter sleep aids during the study.
  • Agree to limit alcohol intake within about 4 hours of bedtime during participation.
  • Agree to limit caffeine intake to 400 mg/day and avoid caffeine after 2:00 PM during the study.
  • Generally healthy without uncontrolled chronic diseases.
  • Resides in the United States.
  • Willing to adhere to all study assessments and restrictions.
Not Eligible

You will not qualify if you...

  • Diagnosed chronic sleep conditions such as insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, or sleep apnea.
  • Current use of sleep-tracking technology that could influence sleep behavior or perception.
  • Women currently undergoing perimenopause or experiencing vasomotor symptoms like night sweats.
  • Use of hormone therapy within the last 3 months.
  • Diagnosed psychiatric disorders with active symptoms including major depressive disorder, bipolar disorder, generalized anxiety disorder, and PTSD.
  • Diagnosed neurodegenerative or chronic pain disorders such as Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia.
  • Regular prescribed stimulant use or current use of CNS-activating antidepressants.
  • Recent use of cannabis or THC-containing products within the past 30 days.
  • Employment in jobs that disrupt nighttime sleep such as night or rotating shifts.
  • Current use of prescription sleep aids or sedative products within 4 weeks prior to enrollment.
  • Allergy or sensitivity to any study product ingredients.
  • Pregnant, breastfeeding, or trying to conceive during the study period.
  • History of substance abuse.
  • Heavy alcohol use (8 or more drinks/week for women or 15 or more drinks/week for men).
  • Participation in another research study now or within the next 7 weeks.
  • Any condition or behavior that might interfere with study participation or data integrity as judged by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Treatment

Duration - 30 days

Participants take the sleep supplement or maintain their usual diet to evaluate effects on evening relaxation, sleep quality, and morning vitality.

5 visits on Days 1, 3, 7, 14, and 30 (may be remote or in-person)

Trial Site Locations

Total: 1 location

1

Alethios (Virtual Study Platform)

San Francisco, California, United States, 94117

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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