Magnesium Supplement for Sleep Quality in Women With Poor Sleep

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Jacksonville University
Study ID
NCT07708857
Status
Not Yet Recruiting

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Conditions

  • Sleep Quality

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Magnesium Breakthrough — DIETARY_SUPPLEMENT
    Magnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.
  • Placebo — DIETARY_SUPPLEMENT
    Matched placebo capsules, identical in color, taste, smell, and packaging to Magnesium Breakthrough; 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.

Study Details

This study will test whether a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood in women ages 35 to 60 who have poor sleep but no diagnosed sleep disorder. Participants will take the magnesium supplement for two weeks and a matched placebo for two weeks, in random order, separated by a one-week washout period. Neither participants nor study staff will know which product is being taken during each period. Throughout the study, participants will wear an Oura Ring to track sleep patterns and will complete short daily and biweekly questionnaires about their sleep, mood, stress, and energy levels. The main measure of interest is change in sleep quality, assessed using a validated sleep questionnaire (the Pittsburgh Sleep Quality Index). The study will also look at effects on mood, stress, and objective sleep measures from the Oura Ring. All study activities - screening, consent, and data collection - are conducted remotely, so participants can take part from anywhere in the United States.

Key Dates

First listed
Jul 16, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Sequence AB (Active-Placebo)
  • Experimental: Arm 2: Sequence BA (Placebo-Active)

Primary Outcome Measure

Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score [ Time Frame: Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellness Discovery LabsJacksonvilleFlorida32202
Heather Hausenblas, PhD
[email protected]
904.891.9746
Stephanie Hooper, MPH
[email protected]
908.868.8740

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By research site
Wellness Discovery Labs· Jacksonville, FL

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