Sleep and Morning Wellbeing program
Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled, Consumer Perception Study
This 30-day test gives a sleep supplement to adults 25–59 who have trouble falling or staying asleep to see if it improves sleep quality and morning wellbeing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 22 Years to 59 Years |
| Sex | All |
| Sponsor | Athletic Greens International Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07311434 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled 30-day interventional trial that gives participants a sleep supplement and collects questionnaire data at predefined time points. Eligible adults complete baseline screening including RU-SATED scoring and must stop other sleep supplements or over-the-counter sleep aids for the study duration. The study is run virtually through the Alethios platform with product shipped to participants and regular online data collection. Outcomes focus on sleep quality, sleep continuity, daytime sleepiness, and morning wellbeing reported by participants.
Who should consider this trial
Good fit: Ideal candidates are generally healthy U.S. residents aged 25–59 with BMI 18.5–29.9 who report poor sleep (RU-SATED score ≤17) and are willing to stop other sleep aids and follow study procedures.
Not a fit: People with uncontrolled chronic disease, those who cannot discontinue other sleep medications or supplements, those outside the age/BMI ranges, or those with sleep disorders requiring medical treatment are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the supplement could offer a short, easy-to-use option to improve sleep quality and how people feel in the morning.
How similar studies have performed: Prior trials of over-the-counter sleep supplements have shown mixed and generally modest short-term improvements in sleep measures, so results are uncertain and may be incremental.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- Alethios (Virtual Study Platform) — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Philip Sapp, PhD, MS — Athletic Greens - AG1
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.