Magnesium Supplement for Sleep Quality

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SH
Overseen ByStephanie Hooper, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Jacksonville University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a magnesium supplement (Magnesium Breakthrough) can enhance sleep quality and mood in women who frequently struggle with sleep but lack a diagnosed sleep disorder. Participants will take the supplement and a placebo (a harmless pill with no active ingredient) at different times without knowing which one they are taking. Women aged 35 to 60, who maintain a regular bedtime routine and do not have a sleep disorder, may be suitable candidates. Participants will use an Oura Ring to track their sleep and complete short surveys about their sleep, mood, and stress. All activities occur remotely, allowing participation from anywhere in the U.S. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance sleep and mood for many women.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that magnesium supplements are generally safe for most people. One study found that magnesium bisglycinate, a type of magnesium in supplements, slightly improved sleep quality in adults with sleep issues. While taking magnesium daily is safe, consuming more than 350 milligrams may cause side effects like diarrhea or an upset stomach.

Another study found that people who took magnesium slept better than those who took a placebo. This study used Magnesium Breakthrough, a supplement that includes several types of magnesium, such as glycinate and citrate, which the body easily absorbs.

Overall, magnesium supplements are considered safe, but it's important to adhere to the recommended doses to avoid any possible side effects.12345

Why are researchers excited about this trial?

Magnesium Breakthrough is unique because it focuses on enhancing sleep quality through the use of magnesium, an essential mineral. Unlike common sleep aids that may rely on synthetic compounds like melatonin or prescription sleep medications, Magnesium Breakthrough takes a more natural approach by potentially addressing magnesium deficiency, which is thought to be linked to poor sleep. Researchers are excited about this treatment because magnesium is involved in over 300 biochemical reactions in the body, including nerve and muscle function, which may help promote relaxation and improve sleep without the side effects often associated with traditional sleep medications.

What evidence suggests that this magnesium supplement might be an effective treatment for improving sleep quality?

Research has shown that magnesium can improve sleep quality. In this trial, participants will receive either an active magnesium supplement or a placebo. One study found that people who took magnesium slept better, felt better, and were more active than those who took a placebo, which contains no active ingredients. Another study found that magnesium bisglycinate specifically helped reduce insomnia symptoms, though the improvement was small. Some research also suggests that magnesium might be particularly helpful for individuals with low magnesium levels. However, the overall benefit might be modest for most people.16789

Who Is on the Research Team?

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Heather Hausenblas, PhD

Principal Investigator

Wellness Discovery Labs, Jacksonville University

Are You a Good Fit for This Trial?

This trial is for women ages 35 to 60 in the U.S. who have trouble sleeping but do not have a diagnosed sleep disorder. All activities are done remotely, so participants can join from home.

Inclusion Criteria

Willing to wear the Oura Ring throughout the entire study period
Consistent bedtime routine (+/-1 hr)
U.S.-based, fluent in English
See 7 more

Exclusion Criteria

I am currently taking supplements with over 25 mg of magnesium daily.
Coffee intake greater than 3 cups per day (or equivalent caffeine from other beverages)
I have kidney disease or take prescription water pills.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
Remote screening

Treatment Period 1

Participants receive either magnesium supplement or placebo for 2 weeks

2 weeks
Remote data collection

Washout

Participants undergo a washout period to minimize carryover effects

1 week
Remote monitoring

Treatment Period 2

Participants receive the alternate treatment (magnesium supplement or placebo) for 2 weeks

2 weeks
Remote data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
Remote follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Magnesium Breakthrough

Trial Overview

The study tests whether taking a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood compared to a placebo. Each participant tries both treatments for two weeks each, with neither they nor staff knowing which is which during the test.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm 2: Sequence BA (Placebo-Active)Experimental Treatment2 Interventions
Group II: Arm 1: Sequence AB (Active-Placebo)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jacksonville University

Lead Sponsor

Trials
4
Recruited
200+

Citations

Magnesium Bisglycinate Supplementation in Healthy Adults ...

Observational research associates greater magnesium consumption with better sleep quality, including shorter sleep onset latency, longer sleep ...

Magnesium Supplement for Sleep Quality in Women With ...

This study will test whether a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood in women ages 35 to 60 who have ...

Effectiveness of Magnesium Supplementation on Sleep ...

The Magnesium Condition had significant improvements compared to the Placebo Condition for sleep quality, mood, and activity outcomes

Can magnesium bisglycinate help improve poor sleep?

Supplementation with magnesium bisglycinate mildly improved insomnia symptoms in this study, but the effect was small and many participants ...

Does Magnesium Help With Sleep? A Closer Look At The ...

magnesium is clinically insignificant for most people - equivalent to just a 1.6-point improvement on a 28-point insomnia scale -designed ...

Magnesium Supplement for Sleep Quality in Women With ...

This study will test whether a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood in women ages 35 to 60 who have ...

7.

sleepfoundation.org

sleepfoundation.org/magnesium

Magnesium for Sleep: Benefits, Types, Dosage, and Side ...

Magnesium supplements are safe for most people to take daily, but taking more than 350 milligrams may cause side effects. Magnesium supplements ...

Magnesium Breakthrough

Because magnesium plays an important role in regulating GABA functions, it can contribute to better sleep quality. The inhibitory actions of ...

Effect of Magnesium Supplementation on Sleep Quality ...

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults.