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CompletedNCT06935123Updated Feb 27, 2026

Impact of Nutritional Supplementation on Sleep Quality

A Phase 1 interventional study of Sleep Supplements and Placebo in Sleep and Sleep Quality, sponsored by Pharmavite LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Pharmavite LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep
  • Sleep Quality

Keywords

  • sleep
  • sleep quality
  • magnesium
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 376 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Pharmavite LLC is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
376 participants (actual)

Study arms

  • Active comparator
    Sleep Supplement 1

    Participants served Sleep Supplement 1

    Dietary Supplement: Sleep Supplements

  • Active comparator
    Sleep Supplement 2

    Participants served Sleep Supplement 2

    Dietary Supplement: Sleep Supplements

  • Active comparator
    Sleep Supplement 3

    Participants served Sleep Supplement 3

    Dietary Supplement: Sleep Supplements

  • Active comparator
    Sleep Supplement 4

    Participants served Sleep Supplement 4

    Dietary Supplement: Sleep Supplements

  • Placebo comparator
    Placebo

    Participants served placebo

    Other: Placebo

Interventions

  • Dietary supplementSleep Supplements

    Sleep supplements

  • OtherPlacebo

    Matching placebo

06

What researchers measure

Primary outcomes

  1. PROMIS Sleep Disturbance 8A

    Perceived sleep quality

    Time frame: 0, 4, 8, and 12 weeks

Secondary outcomes

  1. PROMIS Sleep Related Impairment 8A

    Perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.

    Time frame: 0, 4, 8, and 12 weeks

  2. Insomnia Severity Index (ISI)

    Severity of sleep difficulties and satisfaction with sleep

    Time frame: 0, 4, 8, and 12 weeks

  3. Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)

    Severity of general psychological distress and symptoms related to depression, anxiety, and stress

    Time frame: 0, 4, 8, and 12 weeks

  4. Bristol Stool Scale (BSS)

    Stool frequency and consistency

    Time frame: 0, 4, 8, and 12 weeks

Other outcomes

  1. Safety Objectives

    Occurrence of any Adverse Events (AEs/SAEs)

    Time frame: 0, 4, 8, and 12 weeks

07

Study locations

1 site
  • Atlantia Clinical Trials Inc., 142 E. Ontario, Suite 1200
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06935123
Lead sponsor
Pharmavite LLC
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
May 15, 2025
Primary completion
Sep 26, 2025
Completion
Oct 31, 2025
Last update
Feb 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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