The Effects of a Nutritional Supplement on Sleep Quality

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 Overview

• Status: Recruiting
• Conditions: Sleep; Sleep Quality
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Novel powdered sleep supplement

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: (805) 292-0714; Email: ellen@citruslabs.com

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Citruslabs
      • Contact: Director of Customer Success; Email: jodi@citruslabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin + Flavoring	Dietary supplement: Placebo; maltodextrin placebo
Experimental: Novel Sleep Supplement; Novel powdered sleep supplement	Dietary supplement: Novel powdered sleep supplement; A dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracked sleep activity	Assessed via Oura ring	42 days
Sleep quality	Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly	Baseline, week 3, and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary habits	Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	Baseline and endpoint (week 6)
Oura Actigraphy - Daytime Activity	Daytime activity	42 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Metabolic Blood Panel	Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium, ALT, AST, bilirubin, BUN, creatinine	Baseline and endpoint (week 6)
Complete blood count	Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit	Baseline and endpoint (week 6)

Collaborators and Investigators

• Sponsor: Athletic Greens International
• Investigators: Principal Investigator: Ellen O'Gorman, Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: AG-20801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No