Status:
NOT_YET_RECRUITING
Impact of Nutritional Supplementation on Sleep Quality
Lead Sponsor:
Pharmavite LLC
Conditions:
Sleep
Sleep Quality
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
Eligibility Criteria
Inclusion
- Be able to give written informed consent.
- Be between 18-65 years of age (inclusive).
- Insomnia severity Index score ≤14.
- PROMIS Sleep Disturbance Questionnaire raw score ≥23
- Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- Willing to consume the study product daily for the duration of the study.
Exclusion
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.
- Has a history of drug and/or alcohol abuse.
- Hypersensitive to the contents of the study product.
- Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.
- High caffeine intake, \>400mg/day.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:
- Diagnosed Sleep disorders
- Major psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression)
- Immunocompromised health conditions
- Currently or recently (in the past 4 weeks) taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- Prescribed sleep medications
- Prescribed Medications which impact sleep, including but not limited to sedative hypnotics, anxiolytics, and antidepressants.
- Current or recent (in the past 4 weeks) use of prohibited nutritional and non-nutritional supplements with known or possible sleep effects (e.g. valerian, multivitamins, melatonin)
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT06935123
Start Date
April 11 2025
End Date
October 30 2025
Last Update
April 20 2025
Active Locations (1)
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1
Atlantia Clinical Trials Inc., 142 E. Ontario, Suite 1200
Chicago, Illinois, United States, 60611