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HMB Supplementation and Motor Performance in Sarcopenic Patiens

NCT06801808 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-14

No results posted yet for this study

Summary

Aging is often accompanied by the reduction and weakening of muscle mass, a condition defined as sarcopenia. According to the most recent criteria from the European Working Group on Sarcopenia in Older People, sarcopenia is considered probable when low muscle strength is documented in the patient. The diagnosis of sarcopenia is then confirmed by the presence of reduced muscle mass quantity or quality; it is classified as severe when low muscle strength, reduced muscle quantity and quality, and poor physical performance are all present. According to a recent systematic review of 130 studies, sarcopenia is estimated to affect 10-16% of older adults worldwide. Low muscle strength and rapid atrophy may also result from prolonged immobility, which is an undesirable consequence of hospitalization after illness or injury.

Approximately 65% of elderly patients experience reduced ambulatory function due to hospitalization, and between 30% and 55% report a decline in daily living activities. It has been reported that healthy older adults lose 1 kg (approximately 6%) of lean tissue in the lower limbs after 10 days of bed rest, with a corresponding 16% decline in isokinetic strength of the knee extensors. Muscle atrophy during bed rest is primarily attributed to a marked decrease in skeletal muscle protein synthesis rates, although an accelerated rate of muscle protein degradation compared to synthesis cannot be ruled out. The onset of sarcopenia is further promoted by inflammation, immunosenescence, anabolic resistance, and increased oxidative stress.

Since proper diet, physical activity, and supplementation are currently considered the fundamental pillars for the treatment and prevention of sarcopenia, the identification of a specific food for special medical purposes (AFMS) capable of slowing the progression of sarcopenia is extremely important. Treating sarcopenia also means preventing the associated negative outcomes, including lower overall and progression-free survival rates, postoperative complications, extended hospital stays in patients with various medical conditions, as well as falls and fractures, metabolic disorders, cognitive decline, and mortality in the general population.

Conditions

Interventions

DIETARY_SUPPLEMENT

Myosave

Nutritional supplementation with Myosave

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Silvia MD Giovannini, phD · Fondazione Policlinico Iniversitario A.Gemelli, IRCSS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2027-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06801808 on ClinicalTrials.gov