Effectiveness of the Intake of a Food Supplement Based on Hydroxymethylbutyrate, Carnosine, Lactoferrin and Magnesium on Reduction of Inflammation and on the Improvement of the Health of the Muscle
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Muscle strength evaluation
研究概览
简要总结
This research aims to evaluate the effectiveness of a dietary supplement on reducing inflammation and improving muscle health. The product is a food supplement notified to the Ministry of Health consisting of: hydroxymethylbutyrate, carnosine, lactoferrin and magnesium, which help reduce inflammation and intestinal permeability and to improve muscle health.
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 (Participant)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sarcopenic patients aged 55-
- •Sarcopenia will be diagnosed according to the European Working Group on Sarcopenia in Older People (EWSGOP-2) criteria by muscle strength or chair stand test.
排除标准
- •severe kidney disease (glomerular filtration rate <30 mL/min),
- •moderate-to-severe hepatic failure (Child-Pugh Class of B or C),
- •endocrine diseases associated with disorders of calcium metabolism (with the exception of osteoporosis),
- •psychiatric disorders,
- •cancer (in the previous 5 years),
- •hypersensitivity to any investigational food component
- •subjects taking protein/amino acid supplements (up to 3 months prior to the study).
- •patients not capable of taking oral therapy and those receiving or having indication for artificial nutrition or included in another clinical nutrition trial
结局指标
主要结局
Muscle strength evaluation
时间窗: After 4 months of treatment
Muscle strength was measured by handgrip strength according to standard procedures by a hydraulic hand dynamometer (Jamar 5030 J1, Sammons Preston Rolyan, Bolingbrook, Canada with an accuracy of 0.6 N). The subject holds the dy-namometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body, applying an isometric contraction
Inflammation status
时间窗: After 4 months of treatment
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
body composition assessment
时间窗: After 4 months of treatment
Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).
Gut permeability.
时间窗: After 4 months of treatment
A blood sample will be collected and analised for indican
Physical performance assessment
时间窗: After 4 months of treatment
Physical performance was assessed using the Short Physical Performance battery test (SPPB) which comprised of gait speed, chair-stand test, and balance (three different tests that assess the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); each component was scored from 0 (not possible) to 4 (best performance) and the scores were added up to a total score ranging from 0 to 12.
次要结局
未报告次要终点