NCT05482243Completed
Protein and Exercise Training in Chronic KIDNEY Disease
Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 28 Jul 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 2 Dec 2024
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT05482243
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Jan 2023 to the primary completion date, 2 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.