Magnesium Supplementation as a Nutritional Intervention in Sarcopenia (SARCOMAG)
5. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
352
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Dina F João
- Telefonnummer: +351961647475
- E-post: drjoao@ualg.pt
Studiesteder
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Faro District
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Faro, Faro District, Portugal, 8005-139
- Escola Superior de Saúde - Universidade do Algarve
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Ta kontakt med:
- Dina F João
- Telefonnummer: +351961647475
- E-post: drjoao@ualg.pt
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Hovedetterforsker:
- Dina F João
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Muscle Strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Serum Magnesium Levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Prevalence of Hypomagnesemia
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. januar 2027
Studiet fullført (Antatt)
30. juni 2027
Datoer for studieregistrering
Først innsendt
29. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UAIF201/2025FARO
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
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.
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