Magnesium Supplementation for Body Composition Changes

Overseen By Madison M Doten, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Must not be taking: Steroids, Anabolic agents

Disqualifiers: Smoking, Metabolic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether magnesium intake can alter body composition, such as muscle and fat levels, in physically active individuals. Participants will take a magnesium capsule daily for eight weeks and record their diet and exercise habits. The study seeks individuals who have been physically active for at least a year and have a BMI between 19 and 30. Smokers or those with certain health conditions may not qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to understanding magnesium's effects on active individuals.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that can interfere with body composition. If your current medications fall into this category, you may need to stop taking them to participate.

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

Research has shown that magnesium is generally safe for use. The FDA has evaluated magnesium in dietary supplements and found it safe at normal supplement levels. Studies indicate that magnesium is usually well-tolerated, with only minor side effects, such as an upset stomach, in some cases.

Considering participation in a trial for magnesium supplements, it is reassuring that magnesium has been extensively studied and is widely used as a supplement. No major safety concerns have been reported for magnesium at the dose administered in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about magnesium supplementation for body composition changes because it offers a natural and straightforward approach compared to more invasive or pharmacological interventions. While typical treatments might include dietary adjustments or more complex supplements, magnesium is a simple mineral that plays a crucial role in muscle function and metabolism. This treatment is administered in an extended-release capsule, potentially offering more stable magnesium levels throughout the day, which could enhance its effectiveness and convenience for daily use.

What evidence suggests that magnesium supplementation might be an effective treatment for body composition changes?

Studies have shown that magnesium supplements can increase muscle size and strength, potentially improving body shape. They may also speed up recovery after exercise and reduce muscle soreness. Research suggests a link between higher magnesium intake and a lower risk of obesity, indicating potential benefits for weight management. Additionally, magnesium plays a crucial role in energy use, muscle movement, and protein building. Together, these factors suggest magnesium could positively affect body shape for active individuals. ^{6 7 8 9 10}

Who Is on the Research Team?

Madison M Doten, BS

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for physically active individuals aged 18 to 30 who are interested in how magnesium supplementation might affect their body composition. Participants will need to take a daily magnesium capsule, track their food intake three times a week, and maintain their current exercise routine.

Inclusion Criteria

Classified as a physically active individual for at least 1 year defined as being any individual that regularly engages in the minimum physical activity requirements as put forth by the American College of Sports Medicine

My BMI is between 19 and 30.

Exclusion Criteria

Have pacemakers, implants, or any non-removable metal surgical implants

I am currently using steroids or anabolic agents.

Unwilling to follow study guidelines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Baseline anthropometric measurements and diet analysis are conducted. Supplements for the first 4 weeks are distributed.

1 day

1 visit (in-person)

Treatment

Participants take magnesium capsules daily for 8 weeks, with bi-weekly follow-ups via phone. Midpoint measurements and supplement distribution occur at 4 weeks.

8 weeks

2 visits (in-person), 4 follow-ups (phone)

Follow-up

Final anthropometric measurements and diet analysis are conducted post-intervention.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium

Trial Overview The study is testing whether taking a magnesium supplement every day for eight weeks has an impact on the body's muscle and fat makeup. It includes initial assessments and follow-ups at the midpoint and end of the intervention period.

How Is the Trial Designed?

Group I: Magnesium Supplementation Experimental Treatment 1 Intervention

Life Extension® Extend Release Magnesium 250 mg/day of oral magnesium in capsule form to be taken once a day at breakfast/morning.

Magnesium is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Constipation
• Hypomagnesemia
• Prevention of seizures in eclampsia/preeclampsia
• Acute nephritis (pediatric patients)
• Cardiac arrhythmias secondary to hypomagnesemia

Approved in European Union as Magnesium sulfate for:

• Constipation
• Hypomagnesemia
• Prevention of seizures in eclampsia/preeclampsia
• Acute nephritis (pediatric patients)
• Cardiac arrhythmias secondary to hypomagnesemia

Approved in Canada as Magnesium sulfate for:

• Constipation
• Hypomagnesemia
• Prevention of seizures in eclampsia/preeclampsia
• Acute nephritis (pediatric patients)
• Cardiac arrhythmias secondary to hypomagnesemia

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Life Extension Foundation Inc.

Collaborator

Trials

4

Recruited

70+

Published Research Related to This Trial

In a study of 61 healthy young women, magnesium oxide supplementation for 10 days significantly increased both ionized magnesium levels and total magnesium percentage, indicating its superior bioavailability compared to other forms.

Magnesium citrate led to an increase in the ionized fraction but a decrease in total magnesium concentration, while magnesium carbonate resulted in a decrease in ionized magnesium without affecting total magnesium levels, suggesting varying effects of different magnesium supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term magnesium supplementation on ionized, total magnesium and other relevant electrolytes levels. Ivanovic, ND., Radosavljevic, B., Zekovic, M., et al.[2022]

In a study involving 46 healthy individuals over 60 days, magnesium citrate and amino-acid chelate showed significantly better absorption compared to magnesium oxide, indicating they are more effective forms of magnesium supplementation.

Magnesium citrate not only resulted in the highest serum magnesium levels after both acute and chronic supplementation but also led to the greatest salivary magnesium concentration, suggesting it has superior bioavailability for enhancing magnesium levels in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mg citrate found more bioavailable than other Mg preparations in a randomised, double-blind study. Walker, AF., Marakis, G., Christie, S., et al.[2022]

In a study of 12 healthy young men, daily oral magnesium supplementation for 30 days significantly reduced serum levels of ionized magnesium and intact parathyroid hormone (iPTH), suggesting a potential mechanism for its effects on bone health.

The magnesium supplementation also led to decreased biochemical markers of bone formation and resorption, indicating that it may suppress bone turnover, which could be beneficial in preventing bone loss associated with conditions like osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily oral magnesium supplementation suppresses bone turnover in young adult males. Dimai, HP., Porta, S., Wirnsberger, G., et al.[2015]

In a study of 41 healthy volunteers, oral magnesium oxide significantly increased intracellular magnesium levels and reduced total and LDL cholesterol compared to magnesium citrate, suggesting it may be more effective for improving magnesium status and lipid profiles.

Both magnesium oxide and magnesium citrate treatments effectively reduced platelet aggregation, indicating potential cardiovascular benefits, even in individuals without apparent heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of magnesium status using X-ray dispersion analysis following magnesium oxide and magnesium citrate treatment of healthy subjects. Shechter, M., Saad, T., Shechter, A., et al.[2022]

Magnesium citrate malate (MgCM) is a bioavailable source of magnesium, suitable for use in food supplements providing up to 300-540 mg/day, but the exact extent of its bioavailability compared to other magnesium sources remains unclear due to insufficient comparative data.

At the proposed maximum use levels of MgCM, the intake of magnesium exceeds the established tolerable upper intake level of 250 mg/day, raising potential safety concerns regarding excessive magnesium consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements. Turck, D., Castenmiller, J., De Henauw, S., et al.[2020]

The European Food Safety Authority (EFSA) proposed a new acceptable daily intake (ADI) for glutamate at 30 mg/kg body weight/day, which is lower than typical dietary intake, even for breast-fed infants.

A comprehensive 3-generation reproductive toxicity study in mice showed no adverse effects at doses up to 6,000 mg/kg body weight/day, suggesting that the ADI should be significantly higher, potentially at least 240 mg/kg body weight/day, and that the previous ADI of 'not specified' should remain unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Assessment Paradigm for Glutamate. Roberts, A., Lynch, B., Rietjens, IMCM.[2020]

In a study involving 280 rats on a magnesium-deficient diet, magnesium L-aspartate was found to be the most effective and fastest at compensating for magnesium deficiency compared to 19 other magnesium salts.

Magnesium chloride also showed high efficiency among inorganic salts, and both magnesium chloride and magnesium L-aspartate combined with vitamin B6 significantly improved magnesium levels in the rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative study of magnesium salts bioavailability in rats fed a magnesium-deficient diet]. Spasov, AA., Petrov, VI., Iezhitsa, IN., et al.[2016]

The study found that magnesium supplements, particularly dolomite, can contain significant levels of 210Pb, with the highest activity measured at 2.97 mBq/g.

Taking the recommended daily dose of dolomite magnesium supplements could result in an annual radiation dose of 3.71 µSv from 210Pb decay, highlighting a potential safety concern for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

210Pb in magnesium dietary supplements. Strumińska-Parulska, DI.[2017]

In a study of 179 patients over 10 weeks, the new chewable magnesium tablet TX 1341 was found to be more acceptable and agreeable compared to the reference magnesium MAG2, with 72.7% of patients preferring TX 1341 versus 46.1% for MAG2 (p < 0.01).

TX 1341 also demonstrated better digestive tolerance, resulting in significantly fewer abdominal pain cases (only 2 cases) compared to the reference magnesium, and it led to lower irregular intake rates (8.5% for TX 1341 vs 23.7% for MAG2, p < 0.01).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative study of the short-term acceptability and tolerance of a new oral formulation of magnesium (TX 1341) and a reference magnesium]. Zartarian, M., Perez, JP., Gelas, B., et al.[2015]

In a study of 45 patients undergoing continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA), switching to a calcium-free fluid with a higher magnesium concentration (1.50 mmol/l) significantly improved magnesium balance, reducing the risk of hypomagnesemia.

The use of the higher magnesium fluid allowed for stable magnesium levels without the need for additional magnesium supplementation, demonstrating its efficacy in maintaining adequate magnesium levels during CRRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of High Level Magnesium Dialysis/Substitution Fluid on Magnesium Homeostasis under Regional Citrate Anticoagulation in Critically Ill. Zakharchenko, M., Los, F., Brodska, H., et al.[2018]

Magnesium acetyl taurate significantly increased brain magnesium levels in mice, indicating its effective transition to brain tissue, while magnesium citrate improved muscle and brain magnesium levels regardless of the dose.

Dividing high doses of magnesium compounds into smaller doses did not lead to a significant increase in tissue magnesium levels, suggesting that the timing and formulation of magnesium supplementation may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Dependent Absorption Profile of Different Magnesium Compounds. Ates, M., Kizildag, S., Yuksel, O., et al.[2020]

Recent evidence from 10 studies, including 5 meta-analyses and 5 randomized controlled trials, suggests that magnesium (Mg) supplementation above the current tolerable upper intake level (UL) of 350 mg/d does not significantly increase the risk of diarrhea in adults.

The analysis indicates that higher doses of magnesium (up to 1200 mg/d) can be safely consumed without major gastrointestinal adverse events, supporting the idea that the UL for magnesium should be re-evaluated to potentially allow for greater supplementation and reduce undernutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Call for Re-evaluation of the Tolerable Upper Intake Level for Magnesium Supplementation in Adults. Costello, R., Rosanoff, A., Nielsen, F., et al.[2023]

Physiological oral magnesium supplementation is safe and effective for treating magnesium deficiencies, while pharmacological magnesium therapy can lead to toxicity and should be used cautiously, particularly in acute settings.

Magnesium therapy has specific applications in obstetrics, cardiology, and anesthesia, such as treating eclampsia and certain heart rhythm disorders, but requires careful monitoring to avoid complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium and therapeutics. Durlach, J., Durlach, V., Bac, P., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11508242/

Role of Magnesium in Skeletal Muscle Health and ... Mg supplementation can improve muscle mass, respiratory muscle strength, and exercise recovery and reduce muscle soreness and inflammation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7483156/

Magnesium intake is inversely associated with risk of obesity ... This longitudinal study suggests that Mg intake is inversely associated with incidence of obesity.

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.021783

Effects of Magnesium Citrate, Magnesium Oxide, and ... We observed a significant improvement of arterial stiffness after 24 weeks of magnesium citrate supplementation compared with placebo. Yet it is ...

4. mdpi.com mdpi.com/2072-6643/13/2/320

Magnesium in Obesity, Metabolic Syndrome, and Type 2 ... The supplementation of 380 mg of Mg2+ for 16 weeks improves MetS by reducing blood pressure, hyperglycemia, and hypertriglyceridemia [128], because the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11557730/

Magnesium Matters: A Comprehensive Review of Its Vital ... Mg plays a pivotal role in various physiological processes, including energy metabolism, muscle contraction, protein synthesis, and DNA synthesis.

6. innophos.com innophos.com/download-api/generateproductfileszip?fields=%7B35B0A217-9F5C-40B0-8E85-8662ED8ED18F%7D

SAFETY DATA SHEET Magnesium Glycinate Fortified (Mg ... General information. Get medical attention if any discomfort continues. Show this Safety Data Sheet to the medical personnel. Inhalation. Move affected person ...

7. ods.od.nih.gov ods.od.nih.gov/factsheets/Magnesium-HealthProfessional%20/

Office of Dietary Supplements - Magnesium Magnesium overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions ...

8. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-129328/Magnesium-glycinate-SDS-MedChemExpress.pdf

Magnesium glycinate-SDS-MedChemExpress OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA. Reproductive ...

9. cdn.accentuate.io cdn.accentuate.io/6170804158648/17137213309112/SDS-Magnesium-Glycinate-(Mg-12)-v1613973847211.pdf

SAFETY DATA SHEET Proper personal protective equipment should be selected and worn when handling this product, as based on a risk assessment performed by a qualified person.

10. fda.gov fda.gov/media/155304/download

Petition for a Qualified Health Claim for Magnesium and ... Based on the data and information that FDA considered, FDA concludes that the use of magnesium in dietary supplements, at levels necessary to ...