Magnesium Supplementation as a Nutritional Intervention in Sarcopenia (SARCOMAG)
5 maggio 2026 aggiornato da: Dina Raquel Fernandes João, Escola Superior de Saúde - Universidade do Algarve
Effects of Magnesium Supplementation on Muscle Strength, Muscle Mass, and Physical Performance in Sarcopenic Individuals
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
352
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dina F João
- Numero di telefono: +351961647475
- Email: drjoao@ualg.pt
Luoghi di studio
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Faro District
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Faro, Faro District, Portogallo, 8005-139
- Escola Superior de Saúde - Universidade do Algarve
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Contatto:
- Dina F João
- Numero di telefono: +351961647475
- Email: drjoao@ualg.pt
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Investigatore principale:
- Dina F João
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
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.
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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.
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Sperimentale: Magnesium Supplementation
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Muscle Strength
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Muscle Mass
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Physical Performance
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Serum Magnesium Levels
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Erythrocyte Magnesium Levels
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Inflammation
Lasso di tempo: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Adherence to Supplementation
Lasso di tempo: Up to 12 weeks
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Adherence to the prescribed intervention assessed by capsule count, calculated as the proportion of capsules consumed during the 12-week intervention period.
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Up to 12 weeks
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Safety and Tolerability
Lasso di tempo: Up to 12 weeks
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Occurrence of adverse events and tolerability of magnesium supplementation or placebo assessed through participant reporting and regular monitoring during the intervention period.
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Up to 12 weeks
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Prevalence of Hypomagnesemia
Lasso di tempo: Baseline
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Prevalence of low magnesium status determined by serum and/or erythrocyte magnesium concentrations below established reference values at baseline.
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Baseline
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Prevalence of Sarcopenia
Lasso di tempo: Baseline
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Prevalence of sarcopenia determined at baseline according to the European Working Group on Sarcopenia in Older People (EWGSOP) diagnostic criteria.
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Baseline
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
31 gennaio 2027
Completamento dello studio (Stimato)
30 giugno 2027
Date di iscrizione allo studio
Primo inviato
29 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2026
Primo Inserito (Effettivo)
5 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UAIF201/2025FARO
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
Individual participant data will not be shared due to ethical and data protection constraints.
The study involves an older population considered potentially vulnerable, and informed consent for participation did not include consent for data sharing beyond the research team.
In addition, the risk of re-identification cannot be fully excluded given the detailed clinical and contextual data collected.
Data will be used exclusively for the purposes defined in the approved protocol and in accordance with applicable data protection regulations.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .