Clinical trial NCT06801808: HMB Supplementation and Motor Performance in Sarcopenic Patiens
Official title: Evaluation of HMB Supplementation on Motor Performance in Sarcopenic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Older adults
Nutrition
HMB
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional randomized controlled pilot study
Primary purpose: TREATMENT

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.

Detailed description: Myosave® is an AMFS formulated with a specific blend of β-hydroxy-β-methylbutyrate (HMB), sucrosomial® magnesium, sucrosomial® iron, sucrosomial® vitamin D3, sucrosomial® chromium, and amino acids, for the dietary management of sarcopenia and other conditions characterized by muscle mass loss. HMB is a metabolite of leucine that has an anabolic effect on muscles when taken in combination with physical exercise . In healthy older adults engaging in physical activity, HMB (3 g/day) consumed for 8 weeks tended to increase lean mass gain and significantly improved the percentage of body fat loss compared to the placebo group. Furthermore, daily supplementation with HMB (plus arginine and lysine) in older women over 12 weeks significantly improved function and strength. It therefore seems plausible that HMB supplementation could mitigate muscle loss in bedridden elderly patients.

Based on the existing literature, the aim of the study is to evaluate the contribution of Myosave® supplementation to motor performance, cognitive performance, fatigue, and body composition in post-bedrest sarcopenic patients.

Thirty patients of both sexes will be recruiteed, evaluated and treated at the UOC Cardiovascular Internal Medicine and the UOS Post-Acute Rehabilitation units, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome.

Patients will be divided into two groups by randomization, as specified later. One group (G-MyO), in association with the drug therapy already underway, will take 2 sachets of Myosave® per day for 8 weeks, followed by an 8-week observation period. The other group (G-OMy) will undergo an 8-week observation period first, followed by the intake of 2 sachets of Myosave® per day for an additional 8 weeks.

Eligibility criteria: 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 outcomes:
measure: Hand grip strenght test (HGST)
timeFrame: Change from Baseline HGT at 8 and 16 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline SPPB at 8 and 16 weeks
measure: Time Up&Go Test (TUG)
timeFrame: Change from Baseline TUG at 8 and 16 weeks
measure: Timed 25 Foot Walk (T25FW)
timeFrame: Change from Baseline T25FW at 8 and 16 weeks
measure: Trial Making Test (TMT)
timeFrame: Change from Baseline TMT at 8 and 16 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 8 and 16 weeks
measure: Stroop colour Word Test (SCWT)
timeFrame: Change from Baseline SCWT 8 and 16 weeks
measure: Hospital Anxiety and depression scale (HADS)
timeFrame: Change from Baseline SCWT 8 and 16 weeks
measure: Modified Fatigue Impact scale (MFIS)
timeFrame: Change from Baseline SCWT 8 and 16 weeks
measure: EuroQoL-5D (EQ-5D)
timeFrame: Change from Baseline SCWT 8 and 16 weeks
measure: Mini Nutritional Assessment- short Form (MNA-SF)
timeFrame: Change from Baseline SCWT 8 and 16 weeks
measure: SARC-F
timeFrame: Change from Baseline SCWT 8 and 16 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Iniversitario A.Gemelli, IRCSS
name: Silvia MD Giovannini, phD
role: PRINCIPAL_INVESTIGATOR
References: