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Completed

NCT Number: NCT05482243

Protein and Exercise Training in Chronic KIDNEY Disease

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.

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Key information

Conditions

Kidney Diseases Atrophy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle Loss Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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
  • 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
  • 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.

Treatment and study plan

Whey Protein

Dietary Supplement

Throughout 1 week (either in week 1 or 2), all participants will perform a 1-week resistance type exercise-training program, consisting of two different exercises. Leg press and leg extension exercise will be performed on regular weightlifting machines (Technogym, Rotterdam) at 3 days during the 1-week period (e.g. Monday-Wednesday-Friday). During the resistance exercise training protocol, participants will continue their habitual diet as usual. However, patients with CKD will be provided with a protein supplement following the exercise sessions.

Other names: Resistance exercise

Primary outcomes

  1. Muscle protein synthesis rates

    Time frame: 1-week period

    Muscle protein synthesis rates as measured by the deuterated water method

Secondary outcomes

  1. Physical activity levels

    Time frame: 1-week period

    as measured by accelerometry

  2. Dietary intake (energy/macronutrient)

    Time frame: 1-week period

    as measured by dietary diaries

  3. Leg fat free mass

    Time frame: Baseline

    as measured by DEXA

  4. Body composition

    Time frame: Baseline

    as measured by BIA

  5. Type I and II skeletal muscle fiber size

    Time frame: Baseline

    of muscle biopsy of vastus lateralis

  6. Skeletal muscle mitochondrial bioenergetics

    Time frame: Baseline

    of muscle biopsy of vastus lateralis

  7. Muscle strength

    Time frame: Baseline

    1-RM max testing of leg press and leg extension

  8. Aerobic capacity

    Time frame: Baseline

    VO2-peak test on ergometer

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced Chronic Kidney Disease

Acronym: PET KIDNEY

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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