The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Between-Group Differences in Muscle Mass Changes at 6 Months
研究概览
简要总结
The goal of this clinical trial is to determine whether increasing protein intake in elderly adults with pre-dialysis chronic kidney disease, in combination with resistance exercise, improves muscle mass without worsening renal function.The main questions it aims to answer are:
- Does a protein intake of 1.2 g/kg BW/day combined with exercise improve muscle mass better than a protein intake of 1.0 g/kg BW/day?
- Does a protein intake of 1.2 g/kg BW/day combined with exercise lead to greater improvements in muscle strength and function?
- Does a protein intake of 1.2 1.2 g/kg BW/day combined with exercise cause a decline in renal function (eGFR) compared to a protein intake of 1.0 1.2 g/kg BW/day?
Researchers will compare a group assigned to intake 1.2 g/kg BW/day of protein with another group assigned to intake 1.0 g/kg BW/day, to assess whether the higher intake improves muscle mass and physical performance without causing harm.
Participants will
- be assessed for body composition, physical performance and nutritional intake.
- be assigned to consume protein at either 1.2 or 1.0 g/kg/day.
- perform a home-based resistance exercise program using resistance bands.
- provide blood and urine sample to monitor renal function.
- visit the clinic at weeks 12 and 24 for repeated measurement.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thai adults aged ≥ 65 years
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2
- •Sarcopenia or presarcopenia (diagnosis based on Asian Working Group for Sarcopenia (AWGS) 2019 definition)
排除标准
- •Active cardiopulmonary disease(s) or uncontrolled hypertension with contraindications to resistance training
- •Physically or cognitively unable to participate in the resistance exercise program (e.g. dementia), as determined by the attending physician
- •Limitations of body measurements and interpretation using Bioelectrical Impedance Analysis (BIA) e.g. presence of pacemaker, surgical metal implants
- •Meets the definition of AKI or AKD, defined as alterations in kidney function within the past 3 months
- •Severe vitamin D deficiency (25-OH Vitamin D level < 10 ng/mL)
- •Refuses to give consent to participate in the study
研究组 & 干预措施
Protein intake of 1.2 g/kg/day
干预措施: Protein intake 1.2 g/kg/day and resistance exercise (Behavioral)
Protein intake of 1.0 g/kg/day
干预措施: Protein intake 1.0 g/kg/day and resistance exercise (Behavioral)
结局指标
主要结局
Between-Group Differences in Muscle Mass Changes at 6 Months
时间窗: From enrollment to the end of intervention at 24 weeks
次要结局
未报告次要终点
研究者
Chawalya Angsuwatjarakorn, MD
Principal Investigator
Chulalongkorn University