HMB Supplementation and Motor Performance in Sarcopenic Patiens

NCT06801808 | Not Yet Recruiting

• 1 other identifier: 0000032/25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Sarcopenia

Keywords

Sarcopenia; Older adults; Nutrition; HMB

Outcome Measures

Primary Outcomes (1)

• Hand grip strenght test (HGST)

  HGT is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90° the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart. The average of the three assessments is used as the final value.

  Change from Baseline HGT at 8 and 16 weeks

Secondary Outcomes (11)

• Short Physical Performance Battery (SPPB)

  Change from Baseline SPPB at 8 and 16 weeks

• Time Up&Go Test (TUG)

  Change from Baseline TUG at 8 and 16 weeks

• Timed 25 Foot Walk (T25FW)

  Change from Baseline T25FW at 8 and 16 weeks

• Trial Making Test (TMT)

  Change from Baseline TMT at 8 and 16 weeks

• Symbol Digit Modalities Test (SDMT)

  Change from Baseline SDMT at 8 and 16 weeks

Study Arms (2)

G-MyO group

EXPERIMENTAL

Patients in G-MyO group, in addition to the pharmacological therapy routine, will take 2 sachets of Myosave per day for 8 weeks (T0-T2), followed by no product supplementation for the next 8 weeks (T2-T4)

Dietary Supplement: Myosave

G-OMy group

EXPERIMENTAL

Patients in G-OMy group, without any changes to their pharmacological routine, will not take the product for the first 8 weeks (T0-T2) and will take 2 sachets of Myosave per day for the next 8 weeks (T2-T4)

Dietary Supplement: Myosave

Interventions

Myosave DIETARY_SUPPLEMENT

Nutritional supplementation with Myosave

G-MyO group; G-OMy group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Silvia MD Giovannini, phD

  Fondazione Policlinico Iniversitario A.Gemelli, IRCSS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia MD Giovannini, phD

CONTACT

+390630154382; silvia.giovannini@policlinicogemelli.it

Letizia MS Castelli

CONTACT

+390630154382; letizia.castelli@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Interventional randomized controlled pilot study

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-04

Locations

IT (1)