Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07311434

Sleep and Morning Wellbeing Study

The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.

Recruiting

Interested in participating?

Request Info

Key information

Age range

22 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alethios (Virtual Study Platform)

San Francisco, California, 94117, United States

Location status: Recruiting

Location contact

Zeenia Framroze

CONTACT

[email protected]

6502068006

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female.
  • Age 25-59 years.
  • BMI ≥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 ≤17.
  • Willing and able to follow the study protocol.
  • Willing to discontinue any other supplements (including nootropics, adaptogens, calming herbs), medications, herbal remedies, or over-the-counter sleep medications (e.g., zolpidem, diphenhydramine, Benadryl, ZzzQuil, Unisom, magnesium or melatonin products) used to assist with sleep during the study.
  • Agree to limit alcohol intake within approximately 4 hours of bedtime throughout participation.
  • Agree to limit caffeine intake to ≤400 mg/day (about 3-4 cups of coffee) and avoid ingestion of caffeine-containing products after 2:00 PM during the study period.
  • Generally healthy and not living with any uncontrolled chronic disease.
  • Resides in the United States.
  • Willing to discontinue any restricted products and adhere to all required study assessments.

Exclusion criteria

  • Diagnosed chronic sleep conditions (e.g., insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, sleep apnea).
  • Current use of sleep-tracking technology (e.g., wrist-worn trackers, rings, smartphone apps) that could influence sleep behavior or perception.

Women currently undergoing perimenopause or experiencing vasomotor symptoms (e.g., night sweats).

  • Use of hormone therapy (estrogen, progesterone, phytoestrogens) within the last 3 months.
  • Diagnosed psychiatric disorders including major depressive disorder with acute symptoms, bipolar disorder, generalized anxiety disorder with active symptoms, and PTSD with frequent nightmares.
  • Diagnosed neurodegenerative or chronic pain disorders, including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia.
  • Regular prescribed stimulant use (e.g., amphetamines such as Adderall/Vyvanse; methylphenidate such as Ritalin/Concerta; modafinil/armodafinil).
  • Current use of CNS-activating antidepressants (bupropion, fluoxetine, venlafaxine, sertraline).
  • Current or recent use of cannabis or THC-containing products (recreational or medicinal marijuana, CBD with measurable THC, synthetic cannabinoids) within the past 30 days.
  • Employment in jobs disrupting nighttime sleep (e.g., night shift, rotating shift, excessive travel).
  • Current use of prescription sleep aids.
  • Introduction of any new sleep-related supplements, medications, herbal remedies, or melatonin products during the study.
  • Use of any prescription or OTC products with sedative properties (e.g., melatonin, diphenhydramine, doxylamine, valerian, ZzzQuil, Advil PM) within 4 weeks prior to enrollment or habitual use ≥3 times per week prior to enrollment unless investigator-approved.
  • 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 drinks/week for women or ≥15 drinks/week for men).
  • Participation in another research study now or within the next 7 weeks.
  • Any condition or behavior that, in the investigator's judgment, may interfere with study participation or data integrity.

Treatment and study plan

Sleep Supplement

Dietary Supplement

Powdered sleep supplement

Primary outcomes

  1. Evening relaxation, sleep quality, and morning vitality

    Time frame: Days 1, 3, 7, 14, 30

    Assessed by subjective questionnaire

Other outcomes

  1. Sleep quality

    Time frame: Days 7, 14, and 30

    Assessed by subjective questionnaire

  2. Daytime Sleepiness

    Time frame: Days 1, 7, 14, and 30

    Assessed by subjective questionnaire

Sponsors and collaborators

Lead sponsor

Athletic Greens International

Industry

Registry information

Official study title

Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled, Consumer Perception Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Feb 11, 2026

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.

Published trials that share one or more normalized conditions with this study.