Sleep and Morning Wellbeing Study

NCT07311434 | Recruiting

• 1 other identifier: AGZ001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Relaxation; Stress; Daytime Sleepiness

Outcome Measures

Primary Outcomes (1)

• Evening relaxation, sleep quality, and morning vitality

  Assessed by subjective questionnaire

  Days 1, 3, 7, 14, 30

Other Outcomes (2)

• Sleep quality

  Days 7, 14, and 30

• Daytime Sleepiness

  Days 1, 7, 14, and 30

Study Arms (2)

Sleep Supplement

EXPERIMENTAL

Sleep Supplement

Dietary Supplement: Sleep Supplement

Usual Diet

NO INTERVENTION

Usual Diet

Interventions

Sleep Supplement DIETARY_SUPPLEMENT

Powdered sleep supplement

Sleep Supplement

Eligibility Criteria

• Age: 22 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athletic Greens International: lead

Study Sites (1)

Alethios (Virtual Study Platform)

San Francisco, California, 94117, United States

RECRUITING

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Philip Sapp, PhD, MS

  Athletic Greens - AG1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, clinical trial

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: December 31, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-12

Locations

US (1)