Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Muscle protein synthesis rates
研究概览
简要总结
When patients progress to the final stage of chronic kidney disease (CKD) and require hemodialysis treatment, they typically have lost so much muscle function that they are no longer physically independent. However, due to disease- and hemodialysis-related muscle catabolism, dietary protein and exercise interventions are only capable to attenuate the decline in physical function of patients on hemodialysis treatment. Therefore, lifestyle interventions to increase muscle function should be implemented before hemodialysis is required. However, it is still a matter of debate whether muscle protein synthesis rates of patients with advanced CKD can be increased with a patient-tailored dietary protein and exercise intervention.Therefore, the current study will assess MPS rates during habitual lifestyle and during an interventional program including dietary protein and exercise in patients with advanced CKD. In addition, we will compare MPS rates during free-living conditions between patients with advanced CKD and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be randomized to either start with the habitual lifestyle period or the exercise training period. All randomization procedures will be executed by an independent researcher. Due to the nature of the intervention, blinding of participants and investigators during the exercise training period is not possible. During the analysis, the research technicians will only receive the participant codes to ensure blinding during analysis of blood, saliva, and muscle 2H-enrichment. Thereafter, an independent researcher will provided a blinded dataset to the research team.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, a patient with CKD must meet all of the following criteria:
- •(e)glomerular filtration rate (GFR) <45 ml/min/1.73m2
- •Age: 18 - 80 y
- •Able to provide written informed consent
- •In order to be eligible to participate in this study, a healthy subject must meet all of the following criteria:
- •(e)GFR >60 ml/min/1.73m2 without albuminuria
- •Age: 18 - 80 y
- •Able to provide written informed consent
- •1. A potential subject with CKD who meets any of the following criteria will be excluded from participation in this study:
- •Insulin-dependent diabetes mellitus or two or more oral glucose lowering medications
- •Active inflammatory disease / malignancies
- •Uncontrolled hypertension (>160/100mm Hg), unstable angina pectoris, or arrhythmia
- •Pulmonary disease restricting exercise performance (e.g. COPD)
- •A history of neuromuscular problems
- •Cognitive Impairment
- •Diagnosed GI tract diseases / dysphagia
- •Allergies to milk proteins / Lactose intolerance
- •Pregnancy
- •Hospitalization <1 months prior to study period
- •Participation in any structured exercise program
- •Any medications known to affect protein metabolism (i.e. corticosteroids or prescription strength acne medications).
- •Use of DOAC, vitamin-K-antagonist, or multiple anticoagulants.
- •Dialysis treatment or previous kidney transplantation
- •2. A potential healthy subject who meets any of the following criteria will be excluded from participation in this study:
- •Insulin-dependent diabetes mellitus or two or more oral glucose lowering medications
- •Active inflammatory disease / malignancies
- •Uncontrolled hypertension (>160/100mm Hg), unstable angina pectoris, or arrhythmia
- •Pulmonary disease restricting exercise performance (e.g. COPD)
- •A history of neuromuscular problems
- •Cognitive Impairment
- •Diagnosed GI tract diseases / dysphagia
- •Allergies to milk proteins / Lactose intolerance
- •Pregnancy
- •Hospitalization <1 months prior to study period
- •Participation in any structured exercise program
- •Any medications known to affect protein metabolism (i.e. corticosteroids or prescription strength acne medications).
- •Use of DOAC, vitamin-K-antagonist, or multiple anticoagulants.
排除标准
- 未提供
研究组 & 干预措施
Habitual lifestyle period
- All participants will be encouraged to keep their diet and physical activity similar to before the study period. Subjects will be asked to record their food intake and wear an Actical physical activity monitor for 3 days throughout the habitual lifestyle period (2 week days and 1 weekend day).
- All participants will be asked to ingest 20 mL deuterated water and take a saliva sample daily
Exercise training period
- All participants will be encouraged to keep their diet and physical activity similar to before the study period. Subjects will be asked to record their food intake and wear an Actical physical activity monitor for 3 days throughout the exercise training period (2 week days and 1 weekend day).
- Participants will be asked to ingest 20 mL deuterated water and take a saliva sample daily
- Participants will visit the University three times with 2-day intervals (e.g. Monday-Wednesday-Friday) for an exercise training session as described in 5.6.
- Following the training sessions, participants will be provided with a protein supplement as described in 5.7.
- Before and after ingestion of the protein supplement, participants will be asked to fill in a gastrointestinal tolerance and palatability survey.
干预措施: Whey protein (Dietary Supplement)
结局指标
主要结局
Muscle protein synthesis rates
时间窗: 1-week period
Muscle protein synthesis rates as measured by the deuterated water method
次要结局
- Type I and II skeletal muscle fiber size(Baseline)
- Physical activity levels(1-week period)
- Aerobic capacity(Baseline)
- Leg fat free mass(Baseline)
- Body composition(Baseline)
- Dietary intake (energy/macronutrient)(1-week period)
- Skeletal muscle mitochondrial bioenergetics(Baseline)
- Muscle strength(Baseline)