Impact of Nutritional Supplementation on Sleep Quality

A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Evaluating Nutritional Supplementation On Sleep Quality

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 Overview

• Status: Completed
• Conditions: Sleep; Sleep Quality
• Intervention / Treatment: Other: Placebo; Dietary supplement: Sleep Supplements

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleep Supplement 1; Participants served Sleep Supplement 1	Dietary supplement: Sleep Supplements; Sleep supplements
Active Comparator: Sleep Supplement 2; Participants served Sleep Supplement 2	Dietary supplement: Sleep Supplements; Sleep supplements
Active Comparator: Sleep Supplement 3; Participants served Sleep Supplement 3	Dietary supplement: Sleep Supplements; Sleep supplements
Active Comparator: Sleep Supplement 4; Participants served Sleep Supplement 4	Dietary supplement: Sleep Supplements; Sleep supplements
Placebo Comparator: Placebo; Participants served placebo	Other: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Sleep Disturbance 8A	Perceived sleep quality	0, 4, 8, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Sleep Related Impairment 8A	Perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.	0, 4, 8, and 12 weeks
Insomnia Severity Index (ISI)	Severity of sleep difficulties and satisfaction with sleep	0, 4, 8, and 12 weeks
Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)	Severity of general psychological distress and symptoms related to depression, anxiety, and stress	0, 4, 8, and 12 weeks
Bristol Stool Scale (BSS)	Stool frequency and consistency	0, 4, 8, and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Objectives	Occurrence of any Adverse Events (AEs/SAEs)	0, 4, 8, and 12 weeks

Collaborators and Investigators

• Sponsor: Pharmavite LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sleep; sleep quality; magnesium
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: AFCRO-189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No