NCT07345260 · Athletic Greens International
The Effects of a Nutritional Supplement on Sleep Quality
What this study is about
This study is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Novel powdered sleep supplement
A dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients
DIETARY_SUPPLEMENT
Placebo
maltodextrin placebo
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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
- 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.
Where
- Santa Monica, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations