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SarcopeniaSARCOMAGNCT07567963

Magnesium Supplementation as a Nutritional Intervention in Sarcopenia

A study testing Citrate Magnesium Supplementation in people with Sarcopenia, run by Escola Superior de Saúde - Universidade do Algarve at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia
What is being tested?
Citrate Magnesium Supplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
352 participants
Where
1 sitePortugal
Study dates
1 Jun 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dina F João contact

+351961647475

drjoao@ualg.pt

Portugal1 site
  • Escola Superior de Saúde - Universidade do Algarve

    Faro, Faro District, 8005-139

    Dina F João, +351961647475, drjoao@ualg.pt

    Dina F João

Other trials in Portugal

About this study

Official title: 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.

Read more

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.

Conditions
Sarcopenia
Being tested
Citrate Magnesium Supplementation, Placebo
Keywords
Sarcopenia, Muscle Strength, Muscle Mass, Physical Performance, Aging, Older Adults, Magnesium, Hypomagnesemia, Nutritional Intervention, Supplementation
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Citrate Magnesium SupplementationDietary supplement

    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.

  • PlaceboOther

    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.

Study groups in NCT07567963
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Other: Placebo
Magnesium SupplementationExperimentalParticipants 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.
Receives: Dietary Supplement: Citrate Magnesium Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle Strength

    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.

    Measured: Baseline and 12 weeks

  2. Muscle Mass

    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.

    Measured: Baseline and 12 weeks

  3. Physical Performance

    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.

    Measured: Baseline and 12 weeks

Secondary outcomes (5)
  1. Serum Magnesium Levels

    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.

    Measured: Baseline and 12 weeks

  2. Erythrocyte Magnesium Levels

    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.

    Measured: Baseline and 12 weeks

  3. Inflammation

    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.

    Measured: Baseline and 12 weeks

  4. Adherence to Supplementation

    Adherence to the prescribed intervention assessed by capsule count, calculated as the proportion of capsules consumed during the 12-week intervention period.

    Measured: Up to 12 weeks

  5. Safety and Tolerability

    Occurrence of adverse events and tolerability of magnesium supplementation or placebo assessed through participant reporting and regular monitoring during the intervention period.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567963
Sponsor's protocol ID
UAIF201/2025FARO
Acronym
SARCOMAG
Status last verified
May 2026
First submitted
29 Apr 2026
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Citrate Magnesium Supplementation in people with Sarcopenia, run by Escola Superior de Saúde - Universidade do Algarve at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dina F João (+351961647475, drjoao@ualg.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Strength (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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