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Magnesium Supplementation as a Nutritional Intervention in Sarcopenia (SARCOMAG)

2026年5月5日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

352

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Dina F João
  • 電話番号：+351961647475
  • メール：drjoao@ualg.pt

研究場所

  • ポルトガル
    • Faro District
      • Faro、Faro District、ポルトガル、8005-139
        • Escola Superior de Saúde - Universidade do Algarve
        • コンタクト：
          • Dina F João
          • 電話番号：+351961647475
          • メール：drjoao@ualg.pt
        • 主任研究者：
          • Dina F João

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：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.
他の：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 the intervention will be monitored by capsule count at follow-up visits, and participants will be observed regularly for tolerability and safety.
実験的：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.
ダイエットサプリメント：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 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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Muscle Strength
時間枠：Baseline and 12 weeks
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.
Baseline and 12 weeks
Muscle Mass
時間枠：Baseline and 12 weeks
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.
Baseline and 12 weeks
Physical Performance
時間枠：Baseline and 12 weeks
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.
Baseline and 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Serum Magnesium Levels
時間枠：Baseline and 12 weeks
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.
Baseline and 12 weeks
Erythrocyte Magnesium Levels
時間枠：Baseline and 12 weeks
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.
Baseline and 12 weeks
Inflammation
時間枠：Baseline and 12 weeks
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.
Baseline and 12 weeks
Adherence to Supplementation
時間枠：Up to 12 weeks
Adherence to the prescribed intervention assessed by capsule count, calculated as the proportion of capsules consumed during the 12-week intervention period.
Up to 12 weeks
Safety and Tolerability
時間枠：Up to 12 weeks
Occurrence of adverse events and tolerability of magnesium supplementation or placebo assessed through participant reporting and regular monitoring during the intervention period.
Up to 12 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Prevalence of Hypomagnesemia
時間枠：Baseline
Prevalence of low magnesium status determined by serum and/or erythrocyte magnesium concentrations below established reference values at baseline.
Baseline
Prevalence of Sarcopenia
時間枠：Baseline
Prevalence of sarcopenia determined at baseline according to the European Working Group on Sarcopenia in Older People (EWGSOP) diagnostic criteria.
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Escola Superior de Saúde - Universidade do Algarve

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年1月31日

研究の完了 (推定)

2027年6月30日

試験登録日

最初に提出

2026年4月29日

QC基準を満たした最初の提出物

2026年4月29日

最初の投稿 (実際)

2026年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8日

QC基準を満たした最後の更新が送信されました

2026年5月5日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • UAIF201/2025FARO

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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