The Effects of a Nutritional Supplement on Sleep Quality

NCT07345260 | Recruiting

• 1 other identifier: AG-20801
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Sleep Quality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Dietary habits

  Baseline and endpoint (week 6)

• Oura Actigraphy - Daytime Activity

  42 days

Other Outcomes (2)

• Comprehensive Metabolic Blood Panel

  Baseline and endpoint (week 6)

• Complete blood count

  Baseline and endpoint (week 6)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin + Flavoring

Dietary Supplement: Placebo

Novel Sleep Supplement

EXPERIMENTAL

Novel powdered sleep supplement

Dietary Supplement: Novel powdered sleep supplement

Interventions

Novel powdered sleep supplement DIETARY_SUPPLEMENT

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

Novel Sleep Supplement

Placebo DIETARY_SUPPLEMENT

maltodextrin placebo

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athletic Greens International: lead

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ellen O'Gorman

  Citruslabs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

(805) 292-0714; ellen@citruslabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 15, 2026
• Study Start: January 2, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-12

Locations

US (1)