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Clinical Trials in Italy / NCT06801808
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HMB Supplementation and Motor Performance in Sarcopenic Patiens

NCT06801808 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-09
Last updated
2025-07-14

Condition(s) studied

Sarcopenia

Investigational drug(s) / intervention(s)

Myosave

Myosave: Nutritional supplementation with Myosave

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 50 and 99 years; * Diagnosis of sarcopenia according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP) (Cruz-Jentoft et al., 2018; Kirk et al., 2024), specifically: * Reduced muscle mass, assessed through bioelectrical impedance analysis (Skeletal Mass Index/height value of ≤ 7.0 kg/m² for men and ≤ 5.5 kg/m² for women); * Reduced muscle strength, assessed through the Hand Grip Strength Test (value \< 27 kg for men and \< 16 kg for women); * Reduced physical performance, assessed through gait speed (≤ 0.8 m/s in the 4-meter walking test) and the Short Physical Performance Battery (score ≤ 8). * Cognitive abilities sufficient to follow simple instructions and understand the physiotherapist's guidance (assessed using the Mini Mental State Examination, with a corrected score between 22 and 27). * Ability to walk independently or with minimal assistance; * A history of bed rest lasting at least 5 days; * Ability to understand and sign the informed consent form. Exclusion Criteria: * Presence of a known or suspected allergy/intolerance to one or more ingredients of Myosave; * Presence of kidney or liver diseases; * Use of anticoagulant or antiplatelet drugs; * Presence of uncontrolled hypertension or diabetes; * Oncological diseases, orthopedic or postural issues, presence of plantar ulcers; * Partial or total amputation of foot segments; * Inability to provide informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801808 on ClinicalTrials.gov ↗ ← All trials in Italy