Improving muscle function in chronic kidney disease with protein and exercise
Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced Chronic Kidney Disease
This study is testing if a special diet with more protein and exercise can help people with advanced chronic kidney disease improve their muscle strength before they need dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05482243 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a tailored dietary protein and exercise intervention on muscle protein synthesis rates in patients with advanced chronic kidney disease (CKD). It aims to determine whether these lifestyle changes can enhance muscle function before patients require hemodialysis. Participants will be assessed during their usual lifestyle and during the intervention to evaluate the impact on muscle health. The study focuses on patients with a specific level of kidney function and aims to provide insights into effective pre-dialysis interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with advanced chronic kidney disease and a glomerular filtration rate below 45 ml/min/1.73m2.
Not a fit: Patients with uncontrolled diabetes, active inflammatory diseases, or significant pulmonary or neuromuscular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve muscle function and physical independence in patients with advanced chronic kidney disease.
How similar studies have performed: While there is ongoing debate about the effectiveness of dietary protein and exercise interventions in CKD, similar studies have shown promising results in improving muscle function.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Luc JC van Loon, Prof. Dr. — Maastricht University
- Study coordinator: Floris K Hendriks, M.D.
- Email: f.hendriks@maastrichtuniversity.nl
- Phone: +31655522347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.