SleepNCT07311434
Sleep and Morning Wellbeing Study
A study testing Sleep Supplement in people with Sleep and Relaxation, run by Athletic Greens International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Relaxation, Stress
- What is being tested?
- Sleep Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alethios (Virtual Study Platform)
San Francisco, California, 94117
About this study
Official title: 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.
- Conditions
- Sleep, Relaxation, Stress, Daytime Sleepiness
- Being tested
- Sleep Supplement
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep SupplementDietary supplement
Powdered sleep supplement
| Study group | Role | What they receive |
|---|---|---|
| Sleep Supplement | Experimental | Sleep Supplement Receives: Dietary Supplement: Sleep Supplement |
| Usual Diet | No intervention | Usual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evening relaxation, sleep quality, and morning vitality
Assessed by subjective questionnaire
Measured: Days 1, 3, 7, 14, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start20 Jan 2026
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, clinical trial
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athletic Greens International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Sapp, PhD, MS, Principal investigator, Athletic Greens - AG1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311434
- Sponsor's protocol ID
- AGZ001
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled, Consumer Perception Study
- ClinicalTrials.gov ID
- NCT07311434
- Acronym / sponsor ID
- AGZ001
- Conditions
- Sleep, Relaxation, Stress, Daytime Sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Athletic Greens InternationalIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sleep Supplement | Experimental | Dietary Supplement: Sleep SupplementSleep Supplement |
| Usual Diet | No intervention | –Usual Diet |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep SupplementPowdered sleep supplement | Dietary supplement | Sleep Supplement |
Primary outcome
Evening relaxation, sleep quality, and morning vitality
Time frame: Days 1, 3, 7, 14, 30
Assessed by subjective questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Sapp, PhD, MS principal investigator
Athletic Greens - AG1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Supplement in people with Sleep and Relaxation, run by Athletic Greens International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evening relaxation, sleep quality, and morning vitality (time frame: Days 1, 3, 7, 14, 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.