Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Muscle strength
研究概览
简要总结
The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.
详细描述
There are 45 patients in this study. They are randomly divided into 3 groups which are whey protein isolate group, isolated soy protein group, placebo group. They will take the sample 1 sachet/day for 12 weeks. Muscle strength, muscle mass, physical performance, sarcopenia score, body weight, body mass index, protein, immunoglobulins, quality of life, liver function, kidney function, other laboratory value, and adverse effects are evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 20 years
- •Sarcopenia score more than 4
- •Handgrip strength less than 28 kg in male and less than 18 kg in female and muscle mass less than 7 kg/m2 in male and less than 5.7 kg/m2 in female or Gait speed (6-meter walk) less than 1 m/s
- •Can take protein from animal
- •Can read and write or have people to look after
- •Willing to participate in this study
排除标准
- •Allergic to protein from animals and plants
- •Hepatitis or cirrhosis
- •Glomerular disease or glomerular filtration rate less than 60 ml/min/1.73m2
- •Cancer or heart disease
- •Cannot walk
- •Pregnancy and lactation
- •Duodenal surgery
- •Take protein supplement within 2 weeks
- •Take protein in normal food more than 1.2 g/body weight/day
- •Participating in other studies
结局指标
主要结局
Muscle strength
时间窗: 12 weeks
Using handgrip strength instrument (high value means high strength)
Physical performance
时间窗: 12 weeks
Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.
Body weight
时间窗: 12 weeks
Body weight of the patients
Muscle mass
时间窗: 12 weeks
Using Bioelectrical Impedance Analysis instrument (high value means high mass)
Sarcopenia score
时间窗: 12 weeks
Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)
Body mass index
时间窗: 12 weeks
Body mass index of the patients
次要结局
- Concentration of calcium in serum(12 weeks)
- Concentration of magnesium in serum(12 weeks)
- Concentration of aspartate transaminase in serum(12 weeks)
- Concentration of immunoglobulin in serum(12 weeks)
- Concentration of alkaline phosphatase in serum(12 weeks)
- Respiratory reaction(12 weeks)
- Concentration of glucose in serum(12 weeks)
- Concentration of sodium in serum(12 weeks)
- Concentration of blood urea nitrogen in serum(12 weeks)
- Skin reaction(12 weeks)
- Gastrointestinal tract reaction(12 weeks)
- Hungry feeling(12 weeks)
- Quality of life of the patient(12 weeks)
- Concentration of creatinine in serum(12 weeks)
- Nutritional status(12 weeks)
- Concentration of total protein in serum(12 weeks)
- Concentration of alanine aminotransferase in serum(12 weeks)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University