Protein and Exercise Training in Chronic KIDNEY Disease

Last updated: February 9, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcopenia

Treatment

Whey protein

Clinical Study ID

NCT05482243
METC 22-032
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

  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

  1. 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

  1. 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.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Whey protein
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Maastricht University Medical Center+

    Maastricht, Limburg 6229ER
    Netherlands

    Active - Recruiting

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