Impact of Nutritional Supplementation on Sleep Quality

NCT06935123 | Completed Phase 1

• 1 other identifier: AFCRO-189
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Sleep Quality

Keywords

sleep; sleep quality; magnesium

Outcome Measures

Primary Outcomes (1)

• PROMIS Sleep Disturbance 8A

  Perceived sleep quality

  0, 4, 8, and 12 weeks

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Safety Objectives

  0, 4, 8, and 12 weeks

Study Arms (5)

Sleep Supplement 1

ACTIVE COMPARATOR

Participants served Sleep Supplement 1

Dietary Supplement: Sleep Supplements

Sleep Supplement 2

ACTIVE COMPARATOR

Participants served Sleep Supplement 2

Dietary Supplement: Sleep Supplements

Sleep Supplement 3

ACTIVE COMPARATOR

Participants served Sleep Supplement 3

Dietary Supplement: Sleep Supplements

Sleep Supplement 4

ACTIVE COMPARATOR

Participants served Sleep Supplement 4

Dietary Supplement: Sleep Supplements

Placebo

PLACEBO COMPARATOR

Participants served placebo

Other: Placebo

Interventions

Sleep Supplements DIETARY_SUPPLEMENT

Sleep supplements

Sleep Supplement 1; Sleep Supplement 2; Sleep Supplement 3; Sleep Supplement 4

Placebo OTHER

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmavite LLC: lead

Study Sites (1)

Atlantia Clinical Trials Inc., 142 E. Ontario, Suite 1200

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, Double-Blind, Placebo-Controlled, Parallel

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: May 15, 2025
• Primary Completion: September 26, 2025
• Study Completion: October 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)