Clinical trial NCT06935123: Impact of Nutritional Supplementation on Sleep Quality
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Evaluating Nutritional Supplementation On Sleep Quality
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Sleep
Sleep Quality
Keywords: sleep
sleep quality
magnesium
Lead sponsor: Pharmavite LLC
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, Double-Blind, Placebo-Controlled, Parallel
Primary purpose: TREATMENT

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 Criteria:

1. Be able to give written informed consent.
2. Be between 18-65 years of age (inclusive).
3. Insomnia severity Index score ≤14.
4. PROMIS Sleep Disturbance Questionnaire raw score ≥23
5. Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
6. Willing to consume the study product daily for the duration of the study.

Exclusion Criteria:

1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.
3. Has a history of drug and/or alcohol abuse.
4. Hypersensitive to the contents of the study product.
5. Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.
6. High caffeine intake, \>400mg/day.
7. 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:

   1. Diagnosed Sleep disorders
   2. Major psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression)
   3. Immunocompromised health conditions
8. 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:

   1. Prescribed sleep medications
   2. Prescribed Medications which impact sleep, including but not limited to sedative hypnotics, anxiolytics, and antidepressants.
9. 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)
10. 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.
11. 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.

Primary outcomes:
measure: PROMIS Sleep Disturbance 8A
timeFrame: 0, 4, 8, and 12 weeks
Secondary outcomes:
measure: PROMIS Sleep Related Impairment 8A
timeFrame: 0, 4, 8, and 12 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 0, 4, 8, and 12 weeks
measure: Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
timeFrame: 0, 4, 8, and 12 weeks
measure: Bristol Stool Scale (BSS)
timeFrame: 0, 4, 8, and 12 weeks
Other outcomes:
measure: Safety Objectives
timeFrame: 0, 4, 8, and 12 weeks
Locations:
city: Chicago
country: United States
facility: Atlantia Clinical Trials Inc., 142 E. Ontario, Suite 1200
state: Illinois
Study officials:
References: