Protein and Exercise Training in Chronic KIDNEY Disease

Kidney Diseases Clinical Trial

— PET KIDNEY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482243
• Other study ID #: METC 22-032
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Maastricht University Medical Center
• Contact: Floris K Hendriks, M.D.
• Phone: +31655522347
• Email: f.hendriks[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

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

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Muscle Loss
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Whey protein
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein synthesis rates	Muscle protein synthesis rates as measured by the deuterated water method	1-week period
Secondary	Physical activity levels	as measured by accelerometry	1-week period
Secondary	Dietary intake (energy/macronutrient)	as measured by dietary diaries	1-week period
Secondary	Leg fat free mass	as measured by DEXA	Baseline
Secondary	Body composition	as measured by BIA	Baseline
Secondary	Type I and II skeletal muscle fiber size	of muscle biopsy of vastus lateralis	Baseline
Secondary	Skeletal muscle mitochondrial bioenergetics	of muscle biopsy of vastus lateralis	Baseline
Secondary	Muscle strength	1-RM max testing of leg press and leg extension	Baseline
Secondary	Aerobic capacity	VO2-peak test on ergometer	Baseline