NCT07311434 · Athletic Greens International
Sleep and Morning Wellbeing Study
What this study is about
The study will be a forward-looking randomly assigned, 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Sleep Supplement
Powdered sleep supplement
Primary outcome measures
Evening relaxation, sleep quality, and morning vitality
Time frame: Days 1, 3, 7, 14, 30
Assessed by subjective questionnaire
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations