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

Maastricht University Medical Centre (MUMC) logo

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

    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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

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

Trial contacts and locations

1

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Central trial contact

Floris K Hendriks, M.D.; Luc JC van Loon, Prof. Dr.

Data sourced from clinicaltrials.gov

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