Magnesium Supplementation as a Nutritional Intervention in Sarcopenia

Official title

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

Overview

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.

Interventions

• Dietary supplement Citrate Magnesium Supplementation
  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 gr
• Other Placebo
  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

Primary outcome measures

• Muscle Strength [Time frame: Baseline and 12 weeks]
• Muscle Mass [Time frame: Baseline and 12 weeks]
• Physical Performance [Time frame: Baseline and 12 weeks]

Secondary outcome measures (5)

• Serum Magnesium Levels [Time frame: Baseline and 12 weeks]
• Erythrocyte Magnesium Levels [Time frame: Baseline and 12 weeks]
• Inflammation [Time frame: Baseline and 12 weeks]
• Adherence to Supplementation [Time frame: Up to 12 weeks]
• Safety and Tolerability [Time frame: Up to 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Portugal · 1 center

• Escola Superior de Saúde - Universidade do Algarve — Faro

Identifiers

NCT: NCT07567963 · UAIF201/2025FARO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗