Magnesium Supplementation as a Nutritional Intervention in Sarcopenia (SARCOMAG)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dina F João
- 전화번호: +351961647475
- 이메일: drjoao@ualg.pt
연구 장소
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Faro District
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Faro, Faro District, 포르투갈, 8005-139
- Escola Superior de Saúde - Universidade do Algarve
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연락하다:
- Dina F João
- 전화번호: +351961647475
- 이메일: drjoao@ualg.pt
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수석 연구원:
- Dina F João
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Muscle Strength
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Magnesium Levels
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Prevalence of Hypomagnesemia
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UAIF201/2025FARO
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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