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Kidney DiseasesPET KIDNEYNCT05482243

Protein and Exercise Training in Chronic KIDNEY Disease

A study testing Whey protein in people with Kidney Diseases and Muscle Loss, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Kidney Diseases, Muscle Loss
What is being tested?
Whey protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
1 Jan 2023to 2 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult
  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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center+

    Maastricht, Limburg, 6229ER

Other trials in Netherlands

About this study

Official title: Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced 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.

Being tested
Whey protein
Medical subject headings
Kidney Diseases, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whey proteinDietary supplement

    Also called Resistance exercise

    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.

Study groups in NCT05482243
Study groupRoleWhat they receive
Habitual lifestyle periodNo intervention* 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 periodExperimental* 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.
Receives: Dietary Supplement: Whey protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle protein synthesis rates

    Muscle protein synthesis rates as measured by the deuterated water method

    Measured: 1-week period

Secondary outcomes (8)

  1. Physical activity levels

    as measured by accelerometry

    Measured: 1-week period

  2. Dietary intake (energy/macronutrient)

    as measured by dietary diaries

    Measured: 1-week period

  3. Leg fat free mass

    as measured by DEXA

    Measured: Baseline

  4. Body composition

    as measured by BIA

    Measured: Baseline

  5. Type I and II skeletal muscle fiber size

    of muscle biopsy of vastus lateralis

    Measured: Baseline

  6. Skeletal muscle mitochondrial bioenergetics

    of muscle biopsy of vastus lateralis

    Measured: Baseline

  7. Muscle strength

    1-RM max testing of leg press and leg extension

    Measured: Baseline

  8. Aerobic capacity

    VO2-peak test on ergometer

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start1 Jan 2023
  3. Primary completion2 Dec 2024
  4. Study completion2 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized crossover study (1-week intervention vs. 1-week habitual lifestyle) for both patients with advanced CKD and healthy controls
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482243
Sponsor's protocol ID
METC 22-032
Acronym
PET KIDNEY
Status last verified
Jan 2026
First submitted
28 Jul 2022
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not yet determined

Questions about this trial

What is this clinical trial studying?

A study testing Whey protein in people with Kidney Diseases and Muscle Loss, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle protein synthesis rates (time frame: 1-week period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05482243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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