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NCT Number: NCT07567963

Magnesium Supplementation as a Nutritional Intervention in Sarcopenia

Sarcopenia is a progressive condition common in older adults and is characterized by loss of muscle strength, muscle mass, and physical performance. It is associated with an increased risk of falls, disability, reduced independence, and poorer quality of life. Nutritional interventions are recommended as part of sarcopenia management; however, evidence regarding the role of specific micronutrients remains limited. Magnesium is an essential mineral involved in muscle contraction, neuromuscular function, energy production, and inflammation regulation. Low magnesium status is frequent in older adults and may contribute to muscle impairment and physical decline.

This study aims to evaluate the effects of magnesium supplementation on muscle strength, muscle mass, and physical performance in older adults with sarcopenia living in the eastern Algarve region of Portugal. In addition, the study will assess the prevalence of low magnesium status and sarcopenia in this population.

The study will be conducted in two phases. In the first, observational phase, community-dwelling adults aged 70 years or older will be assessed for sarcopenia according to established diagnostic criteria. Blood samples will be collected to measure serum and erythrocyte magnesium levels and C-reactive protein as an inflammatory marker. Participants diagnosed with sarcopenia and presenting low magnesium levels will be eligible for the second phase.

In the second phase, eligible participants will be randomly assigned to receive either oral magnesium supplementation (400 mg/day of magnesium citrate) or a placebo for 12 weeks, in a double-blind and controlled design. After the intervention period, participants will be reassessed for muscle strength, muscle mass, physical performance, magnesium status, and inflammation.

The results of this study are expected to clarify the role of magnesium supplementation as a nutritional strategy in sarcopenia. Findings may contribute to improving nutritional recommendations and supporting interventions aimed at preserving muscle health, physical function, and quality of life in older adults.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde - Universidade do Algarve

Faro, Faro District, 8005-139, Portugal

Location contact

Dina F João

CONTACT

[email protected]

+351961647475

Dina F João

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 70 years or older
  • Community-dwelling individuals residing in the eastern Algarve region of Portugal
  • Not hospitalized at the time of recruitment
  • Ability to participate in study assessments, regardless of mobility status
  • Ability to provide written informed consent, either personally or via a legally authorized representative when applicable
  • Adequate cognitive ability to collaborate with study procedures, as determined by screening assessment

Exclusion criteria

  • Alcoholism
  • Acute gastrointestinal conditions with symptoms of diarrhea and/or vomiting
  • Presence of conditions associated with magnesium imbalance, including: Electrolyte disorders, Hyperthyroidism, Type 1 diabetes mellitus, Renal disease, Hyperaldosteronism, Short bowel syndrome or history of intestinal resection, Gastric bypass surgery
  • Use of medications known to affect magnesium metabolism, including: Loop or thiazide diuretics (e.g., furosemide, thiazides), Proton pump inhibitors (e.g., omeprazole, pantoprazole, esomeprazole), Cytotoxic agents (e.g., cisplatin, carboplatin, gallium nitrate), Antimicrobial agents such as aminoglycosides, Immunosuppressive agents, Beta-adrenergic agonists (e.g., theophylline, salbutamol, rimiterol), Cetuximab, Cyclosporine A, Pamidronate.

Treatment and study plan

Citrate Magnesium Supplementation

Dietary Supplement

Participants assigned to the experimental arm will receive oral magnesium supplementation administered daily for 12 weeks. The intervention consists of magnesium citrate capsules providing a total daily dose of 400 mg of elemental magnesium. The supplement will be taken according to a standardized dosing schedule identical to that of the placebo group. Magnesium citrate was selected due to its favorable bioavailability. Participants, investigators, and outcome assessors will remain blinded to group assignment throughout the study. Adherence to the intervention will be assessed by capsule count at follow-up visits, and participants will be monitored regularly for tolerability and potential adverse events.

Placebo

Other

Participants assigned to the placebo comparator arm will receive an oral placebo administered daily for 12 weeks. The placebo consists of capsules containing microcrystalline cellulose, an inert substance with no known physiological or therapeutic effects. The placebo capsules are identical in appearance, taste, and packaging to the magnesium supplement to ensure blinding of participants and investigators. The dosing schedule will be the same as that used in the experimental group. Adherence to the intervention will be monitored by capsule count at follow-up visits, and participants will be observed regularly for tolerability and safety.

Primary outcomes

  1. Muscle Strength

    Time frame: Baseline and 12 weeks

    Change in muscle strength assessed by handgrip strength using a calibrated handgrip dynamometer. Handgrip strength will be measured in a seated position, with the elbow flexed at 90 degrees, following standardized procedures. Three measurements will be performed on the non-dominant hand (or dominant hand if necessary), with the highest value recorded. Muscle strength will be evaluated at baseline and after 12 weeks of intervention.

  2. Muscle Mass

    Time frame: Baseline and 12 weeks

    Change in muscle mass assessed by bioelectrical impedance analysis, including appendicular muscle mass and muscle mass adjusted for height. Measurements will be performed at baseline and after 12 weeks of intervention.

  3. Physical Performance

    Time frame: Baseline and 12 weeks

    Change in physical performance assessed by the 4-meter gait speed test, conducted according to standardized procedures. Performance will be assessed at baseline and after 12 weeks of intervention.

Secondary outcomes

  1. Serum Magnesium Levels

    Time frame: Baseline and 12 weeks

    Change in serum magnesium concentration measured from blood samples using standard laboratory procedures. Serum magnesium levels will be assessed at baseline and after 12 weeks of intervention.

  2. Erythrocyte Magnesium Levels

    Time frame: Baseline and 12 weeks

    Change in intracellular magnesium status assessed by erythrocyte magnesium concentration measured from blood samples using validated laboratory methods. Measurements will be performed at baseline and after 12 weeks of intervention.

  3. Inflammation

    Time frame: Baseline and 12 weeks

    Change in systemic inflammation assessed by serum C-reactive protein (CRP) concentration measured using standard laboratory methods. CRP levels will be evaluated at baseline and after 12 weeks of intervention.

  4. Adherence to Supplementation

    Time frame: Up to 12 weeks

    Adherence to the prescribed intervention assessed by capsule count, calculated as the proportion of capsules consumed during the 12-week intervention period.

  5. Safety and Tolerability

    Time frame: Up to 12 weeks

    Occurrence of adverse events and tolerability of magnesium supplementation or placebo assessed through participant reporting and regular monitoring during the intervention period.

Other outcomes

  1. Prevalence of Hypomagnesemia

    Time frame: Baseline

    Prevalence of low magnesium status determined by serum and/or erythrocyte magnesium concentrations below established reference values at baseline.

  2. Prevalence of Sarcopenia

    Time frame: Baseline

    Prevalence of sarcopenia determined at baseline according to the European Working Group on Sarcopenia in Older People (EWGSOP) diagnostic criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Dina F João

CONTACT

[email protected]

+351961647475

Sponsors and collaborators

Lead sponsor

Escola Superior de Saúde - Universidade do Algarve

Other

Registry information

Official study title

Effects of Magnesium Supplementation on Muscle Strength, Muscle Mass, and Physical Performance in Sarcopenic Individuals

Acronym: SARCOMAG

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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