Protein and Exercise Training in Chronic KIDNEY Disease (PET KIDNEY)

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Kidney Diseases; Muscle Loss

Treatments: Dietary Supplement: Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT05482243

METC 22-032

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

3. 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Habitual lifestyle period

No Intervention group

Description:

* All participants will be encouraged to keep their diet and physical activity similar to before the study period. Subjects will be asked to record their food intake and wear an Actical physical activity monitor for 3 days throughout the habitual lifestyle period (2 week days and 1 weekend day). * All participants will be asked to ingest 20 mL deuterated water and take a saliva sample daily

Exercise training period

Experimental group

Description:

* All participants will be encouraged to keep their diet and physical activity similar to before the study period. Subjects will be asked to record their food intake and wear an Actical physical activity monitor for 3 days throughout the exercise training period (2 week days and 1 weekend day). * Participants will be asked to ingest 20 mL deuterated water and take a saliva sample daily * Participants will visit the University three times with 2-day intervals (e.g. Monday-Wednesday-Friday) for an exercise training session as described in 5.6. * Following the training sessions, participants will be provided with a protein supplement as described in 5.7. * Before and after ingestion of the protein supplement, participants will be asked to fill in a gastrointestinal tolerance and palatability survey.

Treatment:

Dietary Supplement: Whey protein