Nutritional supplement to improve sleep quality

The Effects of a Nutritional Supplement on Sleep Quality

This trial will test whether a new powdered dietary supplement helps adults ages 35–65 with mild sleep problems sleep better than a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 35 Years to 65 Years
• Sex: All
• Sponsor: Athletic Greens International (Industry-sponsored)
• Locations: 1 site (Santa Monica, California)
• Trial ID: NCT07345260 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled trial enrolling 140 generally healthy adults with sub-clinical sleep problems (RU-SATED score ≤7). Participants are randomized to receive either the novel powdered supplement or a matching placebo and must stop other sleep-focused supplements or over-the-counter sleep aids for the study duration. Eligible participants are aged 35–65 with BMI 18.5–29.9 and must agree to limits on evening alcohol and caffeine intake. The single-site study is conducted at Citruslabs in Santa Monica, California, and compares sleep-related outcomes between groups.

Who should consider this trial

Good fit: Adults aged 35–65 who are generally healthy, have a BMI between 18.5 and 29.9, report trouble falling or staying asleep with a RU-SATED score ≤7, are willing to stop other sleep supplements/OTC sleep aids, and reside in the United States.

Not a fit: People with diagnosed or uncontrolled chronic sleep disorders, uncontrolled chronic medical conditions, those outside the age or BMI ranges, or those unwilling to discontinue other sleep treatments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the supplement could provide a safe, non-prescription option to improve sleep onset, maintenance, and overall sleep quality for adults with mild sleep disturbances.

How similar studies have performed: Some individual nutritional supplements (for example, melatonin or magnesium) have shown modest, mixed benefits for sleep, but the specific supplement being tested here appears novel and not previously proven in large randomized trials.

Eligibility criteria

Inclusion Criteria:

1. Be male or female
2. Be aged 35-65.
3. Body Mass Index: ≥18.5 and ≤29.9 kg/m2
4. Anyone currently experiencing issues with falling asleep, staying asleep, or waking up during the night
5. Score of 7 or less on the RU-SATED validated sleep questionnaire.
6. Anyone willing to follow the study protocol.
7. 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.
8. Agree to limit alcohol intake within \~4 hours of bedtime
9. 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.
10. Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
11. Resides in the United States.

Exclusion Criteria:

1. 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.
2. Women currently undergoing perimenopause or experiencing vasomotor symptoms such as night sweats.
3. Use of hormone therapy (including estrogen, progesterone, or phytoestrogens) within the last 3 months.
4. Anyone with diagnosed psychiatric disorders including major depressive disorder with acute symptoms, Bipolar disorder, Generalized anxiety disorder with active symptoms, PTSD with frequent nightmares
5. Anyone with diagnosed neurogenitive diseases or chronic pain disorders including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia
6. Anyone who regularly consumes prescribed stimulant medications including Amphetamines (e.g., Adderall, Vyvanse), Methylphenidate (e.g., Ritalin, Concerta), and Modafinil / Armodafinil
7. Anyone currently on CNS activating anti-depressants including Bupropion (Wellbutrin), Fluoxetine, Venlafaxine (Effexor), Sertraline (Zoloft).
8. 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.
9. Anyone with a job that disrupts their nighttime sleep (e.g., excessive travel, night/3rd shift workers).
10. 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
11. Anyone currently taking a prescription sleep aid.
12. Anyone who introduces any new supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of the study.
13. Anyone with any allergies or sensitivities to any of the study product ingredients.
14. Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
15. Anyone with a history of substance abuse.
16. 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).
17. 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 this trial is running

Santa Monica, California

• Citruslabs — Santa Monica, California, United States (Recruiting)

Study contacts

• Principal investigator: Ellen O'Gorman — Citruslabs
• Study coordinator: Principal Investigator

Conditions Sleep; Sleep Quality