Daytime Sleepiness, Relaxation, Sleep, Stress
Conditions
Brief summary
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_SUPPLEMENTSleep Supplement
Powdered sleep supplement
Sponsors
Athletic Greens International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized, controlled, clinical trial
Eligibility
Sex/Gender
ALL
Age
22 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evening relaxation, sleep quality, and morning vitality | Days 1, 3, 7, 14, 30 | Assessed by subjective questionnaire |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhilip Sapp, PhD, MS
Athletic Greens - AG1
Outcome results
None listed