Evaluation of HMB Supplementation on Motor Performance in Sarcopenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hand grip strenght test (HGST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
G-MyO group
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)
干预措施: Myosave (Dietary Supplement)
G-OMy group
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)
干预措施: Myosave (Dietary Supplement)
结局指标
主要结局
Hand grip strenght test (HGST)
时间窗: Change from Baseline HGT at 8 and 16 weeks
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.
次要结局
- 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)
- Stroop colour Word Test (SCWT)(Change from Baseline SCWT 8 and 16 weeks)
- Hospital Anxiety and depression scale (HADS)(Change from Baseline SCWT 8 and 16 weeks)
- Modified Fatigue Impact scale (MFIS)(Change from Baseline SCWT 8 and 16 weeks)
- EuroQoL-5D (EQ-5D)(Change from Baseline SCWT 8 and 16 weeks)
- Mini Nutritional Assessment- short Form (MNA-SF)(Change from Baseline SCWT 8 and 16 weeks)
- SARC-F(Change from Baseline SCWT 8 and 16 weeks)
研究者
GIOVANNINI SILVIA
Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS