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NCT Number: NCT07345260

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.

Recruiting

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Location status: Recruiting

Location contact

Director of Customer Success

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel powdered sleep supplement

Dietary Supplement

A dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients

Placebo

Dietary Supplement

maltodextrin placebo

Primary outcomes

  1. Tracked sleep activity

    Time frame: 42 days

    Assessed via Oura ring

  2. Sleep quality

    Time frame: Baseline, week 3, and week 6

    Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly

Secondary outcomes

  1. Dietary habits

    Time frame: Baseline and endpoint (week 6)

    Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool

  2. Oura Actigraphy - Daytime Activity

    Time frame: 42 days

    Daytime activity

Other outcomes

  1. Comprehensive Metabolic Blood Panel

    Time frame: Baseline and endpoint (week 6)

    Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium, ALT, AST, bilirubin, BUN, creatinine

  2. Complete blood count

    Time frame: Baseline and endpoint (week 6)

    Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

(805) 292-0714

Sponsors and collaborators

Lead sponsor

Athletic Greens International

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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