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Search / Trial NCT05482243

Protein and Exercise Training in Chronic KIDNEY Disease

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jul 28, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how a tailored diet rich in protein and exercise training can help improve muscle function in patients with advanced chronic kidney disease (CKD) before they need hemodialysis. The goal is to see if these lifestyle changes can boost muscle protein synthesis, which is the process that helps build and maintain muscle. The trial will compare how well muscle protein synthesis works in patients with CKD versus healthy individuals.

To participate, patients with CKD need to be between 18 and 80 years old and have a specific level of kidney function, while healthy participants should also be between 18 and 80 but with better kidney function. Participants will be closely monitored during the study to understand the effects of the dietary and exercise program. It's important to know that certain health conditions and medications may exclude individuals from the trial to ensure everyone's safety. Overall, this study aims to find effective ways to help maintain muscle strength and physical independence in those facing kidney challenges.

Gender

ALL

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.

About Maastricht University Medical Center

Maastricht University Medical Center (MUMC+) is a leading academic medical center in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, MUMC+ integrates cutting-edge scientific inquiry with clinical practice, focusing on a wide range of medical disciplines. The center emphasizes collaboration among multidisciplinary teams, fostering an environment that promotes excellence in patient care and the translation of research findings into clinical applications. MUMC+ is dedicated to improving health outcomes and enhancing quality of life through rigorous clinical investigations and the development of novel therapeutic strategies.

Locations

Maastricht, Limburg, Netherlands

Patients applied

0 patients applied

Trial Officials

Luc JC van Loon, Prof. Dr.

Principal Investigator

Maastricht University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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