SleepNCT07345260
The Effects of a Nutritional Supplement on Sleep Quality
A study testing Novel powdered sleep supplement in people with Sleep and Sleep Quality, run by Athletic Greens International at 1 site in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Quality
- What is being tested?
- Novel powdered sleep supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female
- Be aged 35-65.
- Body Mass Index: ≥18.5 and ≤29.9 kg/m2
- Anyone currently experiencing issues with falling asleep, staying asleep, or waking up during the night
- Score of 7 or less on the RU-SATED validated sleep questionnaire.
- Anyone willing to follow the study protocol.
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- Anyone willing to discontinue any other supplements (nootroptics, adaptogens, calming herbs), medications, herbal remedies, over the counter sleep medications [e.g., zolipidem, diphenhydramine (Benadryl or unisom), magnesium or melatonin products] used to assist with sleep for the duration of the study.
- Agree to limit alcohol intake within ~4 hours of bedtime
- Agree to limit caffeine intake to ≤ 400 mg/day (~3-4 cups of coffee) or ingestion of caffeine-containing products after 2:00 PM during the study period.
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- Resides in the United States.
Who cannot join
- Anyone with a diagnosed chronic sleep condition, including but not limited to insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome (RLS), or sleep apnea.
- Women currently undergoing perimenopause or experiencing vasomotor symptoms such as night sweats.
- Use of hormone therapy (including estrogen, progesterone, or phytoestrogens) within the last 3 months.
- Anyone with diagnosed psychiatric disorders including major depressive disorder with acute symptoms, Bipolar disorder, Generalized anxiety disorder with active symptoms, PTSD with frequent nightmares
- Anyone with diagnosed neurogenitive diseases or chronic pain disorders including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia
- Anyone who regularly consumes prescribed stimulant medications including Amphetamines (e.g., Adderall, Vyvanse), Methylphenidate (e.g., Ritalin, Concerta), and Modafinil / Armodafinil
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- Anyone currently on CNS activating anti-depressants including Bupropion (Wellbutrin), Fluoxetine, Venlafaxine (Effexor), Sertraline (Zoloft).
- Current or recent use of cannabis or THC-containing products, including recreational or medicinal marijuana, CBD products with measurable THC content, or synthetic cannabinoids, within the past 30 days.
- Anyone with a job that disrupts their nighttime sleep (e.g., excessive travel, night/3rd shift workers).
- Anyone unwilling to wear the Oura ring device for the duration of the trial or unwilling to open the Oura application at least three times each week during the trial for data to sync to the cloud
- Anyone currently taking a prescription sleep aid.
- Anyone who introduces any new supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of the study.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone with a history of substance abuse.
- Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- Currently partaking in another research study or will be partaking in any other research study for the next 7 weeks, or at any point during this study's duration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Citruslabs
Santa Monica, California, 90404
Director of Customer Success, jodi@citruslabs.com
About this study
This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes.
- Conditions
- Sleep, Sleep Quality
- Being tested
- Novel powdered sleep supplement, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel powdered sleep supplementDietary supplement
A dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients
PlaceboDietary supplement
maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin + Flavoring Receives: Dietary Supplement: Placebo |
| Novel Sleep Supplement | Experimental | Novel powdered sleep supplement Receives: Dietary Supplement: Novel powdered sleep supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracked sleep activity
Assessed via Oura ring
Measured: 42 days
Sleep quality
Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly
Measured: Baseline, week 3, and week 6
Secondary outcomes (2)
Dietary habits
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: Baseline and endpoint (week 6)
Oura Actigraphy - Daytime Activity
Daytime activity
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Jan 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athletic Greens International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ellen O'Gorman, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345260
- Sponsor's protocol ID
- AG-20801
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nutritional Supplement on Sleep Quality
- ClinicalTrials.gov ID
- NCT07345260
- Acronym / sponsor ID
- AG-20801
- Conditions
- Sleep, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Athletic Greens InternationalIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin + Flavoring |
| Novel Sleep Supplement | Experimental | Dietary Supplement: Novel powdered sleep supplementNovel powdered sleep supplement |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be male or female
- Be aged 35-65.
- Body Mass Index: ≥18.5 and ≤29.9 kg/m2
- Anyone currently experiencing issues with falling asleep, staying asleep, or waking up during the night
- Score of 7 or less on the RU-SATED validated sleep questionnaire.
Key exclusion criteria (17 listed)
- Anyone with a diagnosed chronic sleep condition, including but not limited to insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome (RLS), or sleep apnea.
- Women currently undergoing perimenopause or experiencing vasomotor symptoms such as night sweats.
- Use of hormone therapy (including estrogen, progesterone, or phytoestrogens) within the last 3 months.
- Anyone with diagnosed psychiatric disorders including major depressive disorder with acute symptoms, Bipolar disorder, Generalized anxiety disorder with active symptoms, PTSD with frequent nightmares
- Anyone with diagnosed neurogenitive diseases or chronic pain disorders including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia
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 |
|---|---|---|
| Novel powdered sleep supplementA dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients | Dietary supplement | Novel Sleep Supplement |
| Placebomaltodextrin placebo | Dietary supplement | Placebo |
Primary outcome
Tracked sleep activity
Time frame: 42 days
Assessed via Oura ring
Sleep quality
Time frame: Baseline, week 3, and week 6
Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly
2 secondary outcomes
Dietary habits
Time frame: Baseline and endpoint (week 6)
Oura Actigraphy - Daytime Activity
Time frame: 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Ellen O'Gorman principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel powdered sleep supplement in people with Sleep and Sleep Quality, 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 10 Feb 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator ((805) 292-0714, ellen@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracked sleep activity (time frame: 42 days). The study lists 2 primary outcomes in all. 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 10 Feb 2026.