Magnesium Supplementation as a Nutritional Intervention in Sarcopenia (SARCOMAG)

Escola Superior de Saúde - Universidade do Algarve

Status: Not yet enrolling

Conditions: Sarcopenia

Treatments: Dietary Supplement: Citrate Magnesium Supplementation; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07567963

UAIF201/2025FARO

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants assigned to the placebo comparator group will receive an oral placebo administered daily for 12 weeks. The placebo consists of capsules containing microcrystalline cellulose, an inert substance with no known biological effects. The placebo capsules are identical in appearance, taste, and packaging to the magnesium supplement, ensuring blinding of participants and investigators. Participants will be instructed to take the capsules according to the same schedule as the intervention group. Adherence will be monitored through capsule count at follow-up visits.

Treatment:

Other: Placebo

Magnesium Supplementation

Experimental group

Description:

Participants assigned to the experimental arm will receive oral magnesium supplementation administered daily for a period of 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 and investigators will remain blinded to treatment allocation 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.

Treatment:

Dietary Supplement: Citrate Magnesium Supplementation