Sleep and Morning Wellbeing Study

NCT ID: NCT07311434

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Relaxation Stress Daytime Sleepiness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep Supplement

Sleep Supplement

Group Type EXPERIMENTAL

Sleep Supplement

Intervention Type DIETARY_SUPPLEMENT

Powdered sleep supplement

Usual Diet

Usual Diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sleep Supplement

Powdered sleep supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 ≤7. 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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Athletic Greens International

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Sapp, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Athletic Greens - AG1

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alethios (Virtual Study Platform)

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zeenia Framroze

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AGZ001

Identifier Type: -

Identifier Source: org_study_id