Effects of Creatine Supplementation in Sarcopenic and Non-sarcopenic Patients on Chronic Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use
研究概览
简要总结
Adult patients undergoing chronic dialysis therapy for at least three months were selected. A physical function assessment was conducted, including the Short Physical Performance Battery (SPPB) and a handgrip strength test. Additionally, a bioelectrical impedance analysis was performed. Subsequently, 5 grams of creatine were administered daily for a period of eight weeks, after which the same assessments were repeated. The results were then analyzed to identify any differences in the tests, aiming to detect potential changes following creatine supplementation.
详细描述
Adult patients undergoing chronic dialysis therapy for at least three months were selected, primarily based on their good adherence to pharmacological and dialysis treatment regimens. A physical function assessment was conducted, including the Short Physical Performance Battery (SPPB) and a handgrip strength test. Additionally, a bioelectrical impedance analysis was performed.
All participants were informed that creatine would be administered and provided written informed consent. The study protocol was approved by the local ethics committee.
Creatine supplementation consisted of 5 grams per day for eight weeks. On dialysis days, the dose was administered immediately after the dialysis session. On non-dialysis days, patients were responsible for self-administering the creatine at home. The creatine was diluted in 100 mL of water before ingestion.
All assessments were conducted the day following the second dialysis session of the week-on Thursday or Friday, depending on the patient's schedule. There was no control group so pre-creatine measurements were considered as the basal (control) state. Measurements were taken before and after the creatine supplementation period in the same patients. The data were analyzed to evaluate changes in the outcomes following creatine use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible to provide informed consent
- •At least three months on chronic dialysis therapy
- •No physical impairments that would prevent completion of the SPPB or bioelectrical impedance analysis
排除标准
- •Pregnancy
- •Use of any nutritional supplement
研究组 & 干预措施
Pre creatine and post
patients before and after creatine suplemmentation
干预措施: Creatine (Dietary Supplement)
结局指标
主要结局
Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use
时间窗: eigth weeks
To compare the physical functionality status of selected patients, as assessed by the Short Physical Performance Battery (SPPB), before and after eight weeks of creatine supplementation. Scale range between 0-12 points. Higher points mean a better outcome (higher physical functionality).
次要结局
- Compare hand grip strength as assessed by a hand dynamometer, before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: skeletal muscle mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: fat free mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: total body water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: extracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: intracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: phase angle (degrees), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
研究者
Carla Basualto Alarcón
Associate Professor, U Aysen. MD., MSc., PhD.
Universidad de Aysén