NCT06935123Not yet recruitingPhase 1
A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Evaluating Nutritional Supplementation On Sleep Quality
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Pharmavite LLC
- Enrollment
- 376
- Locations
- 1
- Primary Endpoint
- PROMIS Sleep Disturbance 8A
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be able to give written informed consent.
- •Be between 18-65 years of age (inclusive).
- •Insomnia severity Index score ≤
- •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 Criteria
- •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.
Arms & Interventions
Sleep Supplement 1
Active Comparator
Participants served Sleep Supplement 1
Intervention: Sleep Supplements (Dietary Supplement)
Sleep Supplement 2
Active Comparator
Participants served Sleep Supplement 2
Intervention: Sleep Supplements (Dietary Supplement)
Sleep Supplement 3
Active Comparator
Participants served Sleep Supplement 3
Intervention: Sleep Supplements (Dietary Supplement)
Sleep Supplement 4
Active Comparator
Participants served Sleep Supplement 4
Intervention: Sleep Supplements (Dietary Supplement)
Placebo
Placebo Comparator
Participants served placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
PROMIS Sleep Disturbance 8A
Time Frame: 0, 4, 8, and 12 weeks
Perceived sleep quality
Secondary Outcomes
- PROMIS Sleep Related Impairment 8A(0, 4, 8, and 12 weeks)
- Insomnia Severity Index (ISI)(0, 4, 8, and 12 weeks)
- Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)(0, 4, 8, and 12 weeks)
- Bristol Stool Scale (BSS)(0, 4, 8, and 12 weeks)
Investigators
Study Sites (1)
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