Clinical trial NCT05482243: Protein and Exercise Training in Chronic KIDNEY Disease
Official title: Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Diseases
Muscle Loss
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover study (1-week intervention vs. 1-week habitual lifestyle) for both patients with advanced CKD and healthy controls
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 1. 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
2. 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.

Primary outcomes:
measure: Muscle protein synthesis rates
timeFrame: 1-week period
Secondary outcomes:
measure: Physical activity levels
timeFrame: 1-week period
measure: Dietary intake (energy/macronutrient)
timeFrame: 1-week period
measure: Leg fat free mass
timeFrame: Baseline
measure: Body composition
timeFrame: Baseline
measure: Type I and II skeletal muscle fiber size
timeFrame: Baseline
measure: Skeletal muscle mitochondrial bioenergetics
timeFrame: Baseline
measure: Muscle strength
timeFrame: Baseline
measure: Aerobic capacity
timeFrame: Baseline
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
affiliation: Maastricht University
name: Luc JC van Loon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: