Sleep and Morning Wellbeing Study

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

Study Overview

• Status: Recruiting
• Conditions: Stress; Sleep; Relaxation; Daytime Sleepiness
• Intervention / Treatment: Dietary supplement: Sleep Supplement

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94117
      • Recruiting
      • Alethios (Virtual Study Platform)
      • Contact: Zeenia Framroze; Phone Number: 6502068006; Email: support@alethios.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Supplement	Dietary supplement: Sleep Supplement; Powdered sleep supplement
No Intervention: Usual Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evening relaxation, sleep quality, and morning vitality	Assessed by subjective questionnaire	Days 1, 3, 7, 14, 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Assessed by subjective questionnaire	Days 7, 14, and 30
Daytime Sleepiness	Assessed by subjective questionnaire	Days 1, 7, 14, and 30

Collaborators and Investigators

• Sponsor: Athletic Greens International
• Investigators: Principal Investigator: Philip Sapp, PhD, MS, Athletic Greens - AG1

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence
• Other Study ID Numbers: AGZ001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No