Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- hand grip strength
研究概览
简要总结
HINEX Jelly is a jelly high protein supplement. This report is to investigate whether jelly high protein supplement can achieve greater muscle mass, muscle strength, physical performance and nutritional status in sarcopenia or possible sarcopenia subjects. It is 20 weeks randomized, crossover, self-controlled trials. The screening, recruitment and trial period were carried out from Feb, 2022 to Mar, 2023. Patients were randomized to either a self-controlled phase,which intake 400~500 kcal breakfast, or a supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks. After a 4-week washout they cross over to the alternate treatment. The anthropometric measurements, sarcopenia parameters, nutritional assessment and hematology assessment data were measured at the week 0,8,12,20 and 24-hour dietary record were recorded at week 1,8,13,20.
详细描述
Parameters of sarcopenia, including the muscle mass assessment, handgrip strength and physical performance assessment.Muscle mass and body composition were measured by bioelectrical impedance analysis (BIA). A hand dynamometer was used to measure handgrip strength. Physical performance was measured by short physical performance battery (SPPB), 6-meter gait speed and 5-time chair stand test. Mini nutritional assessment (MNA) used to measure nutritional status. The hematology assessment including total protein, albumin, pre-albumin, transferrin, c-reactive protein (CRP), vitamin D, calcium, glucose, insulin, homeostasis model assessment-estimated insulin resistance (HOMA-IR), total cholesterol, triacylglycerol, creatinine, creatine-kinase, alkaline phosphatase, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) and complete blood count.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-85 years old, middle-aged and elderly subjects with possible sarcopenia or sarcopenia. According to AWGS 2019, possible sarcopenia is defined as (1) handgrip strength < 28 kg in men and < 18 kg in women or (2) 5-time chair stand test ≥ 12 seconds; sarcopenia is defined as meet (1) or (2) plus appendicular skeletal muscle mass index (ASMI) < 7.0 kg/m2 in men and < 5.7 kg/m2 in women.
排除标准
- •BMI>35 kg/m2, Taking any special diet (i.e. vegan), be allergic to ingredient (i.e. milk or soy bean) and any seriously acute or chronic lung, liver, kidney, gastrointestinal, cancers diseases history.
结局指标
主要结局
hand grip strength
时间窗: week 0,8,12,20
the change of hand grip strength as the marker of muscle strength.Measured via hand grip dynamometry.
muscle mass
时间窗: week 0,8,12,20
the change of muscle mass and measured via bioelectrical impedance analysis(BIA)
5-time chair stand test
时间窗: week 0,8,12,20
the change of 5-time chair stand test as the marker of physical performance.
次要结局
- short physical performance battery(week 0,8,12,20)
- 6-meter gait speed(week 0,8,12,20)
- Mini nutritional assessment(week 0,8,12,20)