Magnesium Supplementation for Relaxation in Healthy Adults

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Olly, PBC

Must not be taking: Antidepressants, Sedatives, Stimulants, others

Disqualifiers: Neurological, Psychiatric, Pregnancy, Allergies, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether magnesium supplements can help people feel more relaxed and sleep better. Participants will take either a magnesium or placebo gummy daily for 12 weeks and answer questions about their stress and sleep. The study seeks healthy individuals who can maintain their usual diet and exercise routines. As an unphased trial, it aims to contribute to understanding the potential benefits of magnesium for relaxation and sleep.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes people taking medications that interact with magnesium or affect the central nervous system, among others. It's best to discuss your current medications with the trial team to see if you qualify.

Is there any evidence suggesting that magnesium supplementation is likely to be safe for humans?

Research has shown that magnesium supplements are generally safe for adults if the dose remains below 350 mg per day. Most studies have used magnesium oxide and tested doses up to 729 mg without major issues, though the recommended safe dose is 350 mg per day.

Some studies suggest that magnesium can alleviate stress and muscle soreness. Many individuals taking magnesium supplements report fewer muscle aches and improved recovery after exercise.

Mild side effects, such as diarrhea, can occur but are uncommon. Overall, most people tolerate magnesium well when adhering to the recommended amounts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard relaxation treatments like meditation or yoga, magnesium supplementation is unique because it taps into the body's natural mineral balance to promote relaxation. Magnesium is known to play a crucial role in regulating nerve and muscle function, which can help reduce stress and tension. Researchers are excited about this treatment because it offers a simple, non-invasive way to potentially enhance relaxation without the need for more intensive interventions. Plus, with its convenient gummy form, it’s easy and enjoyable to incorporate into daily routines.

What evidence suggests that magnesium supplementation might be an effective treatment for relaxation?

Studies have shown that magnesium supplements can improve sleep and reduce anxiety. Specifically, magnesium-L-threonate enhances sleep quality, particularly in deep and REM sleep stages, and boosts mood and energy. Other research suggests higher doses of magnesium may be more effective for managing anxiety and sleep issues. Additionally, magnesium has been linked to reduced muscle soreness and better recovery, aiding relaxation and stress reduction. This trial will compare a dietary supplement containing magnesium with a placebo to evaluate its effectiveness in improving relaxation and sleep quality in healthy adults. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in improving relaxation and sleep. Participants will take a daily supplement or placebo for 12 weeks, with monthly check-ins to monitor progress.

Inclusion Criteria

Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.

I am a healthy individual.

Will maintain regular diet and exercise habits

Exclusion Criteria

I am not taking any allergy medication except for non-sedating antihistamines.

Known allergies to magnesium-containing products

I am taking blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take magnesium or placebo supplements daily for 12 weeks, with monthly check-ins and questionnaires

12 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Supplementation

Trial Overview The study tests whether magnesium supplementation can enhance body and mind relaxation, as well as improve sleep quality compared to a placebo. The effectiveness is measured through validated questionnaires.

How Is the Trial Designed?

Group I: Dietary Supplement with actives Active Control 1 Intervention

Oral dietary supplement. Instructions: Take 4 gummy per day with or without food or water. Chew thoroughly before swallowing. Do not take more than 4 gummy per day.

Group II: Placebo Placebo Group 1 Intervention

Oral dietary supplement. Instructions: Take 4 gummy per day with or without food or water. Chew thoroughly before swallowing. Do not take more than 4 gummy per day.

Who Is Running the Clinical Trial?

Olly, PBC

Lead Sponsor

Trials

4

Recruited

260+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11136869/

Examining the Effects of Supplemental Magnesium on Self ... However, higher doses of magnesium appear to be more effective in addressing anxiety and sleep disturbances, as all studies with negative ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7761127/

Magnesium Status and Stress: The Vicious Circle Concept ... Impact of magnesium supplementation, in combination with vitamin B6, on stress and magnesium status: Secondary data from a randomised controlled trial.

3. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05434-x

Effects of magnesium supplementation on muscle soreness in ... Results. These studies showed that MgS reduced muscle soreness, improved performance, recovery and induced a protective effect on muscle damage.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590142724000193

Magnesium-L-threonate improves sleep quality and ... This showed MgT improved sleep quality, especially deep/REM sleep stages, improved mood, energy, alertness, and daily activity and productivity.

5. mdpi.com mdpi.com/2076-3921/14/6/740

Unlocking the Power of Magnesium: A Systematic Review ... While results showed a statistically significant reduction in CRP levels, suggesting an anti-inflammatory effect, no conclusive impact on oxidative stress ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507250/

Magnesium and stress - NCBI - NIH Magnesium status is highly associated with stress levels, with both stress and hypomagnesemia potentiating each other's negative effects.

7. mdpi.com mdpi.com/2072-6643/9/5/429

The Effects of Magnesium Supplementation on Subjective ... This systematic review examines the available evidence for the efficacy of Mg supplementation in the alleviation of subjective measures of anxiety and stress.

8. aafp.org aafp.org/pubs/afp/issues/2009/0715/p157.html

Therapeutic Uses of Magnesium Oral magnesium supplementation is safe in adults when used in dosages below the upper intake level of 350 mg per day (elemental magnesium).