Protein and Exercise Training in Chronic KIDNEY Disease

Not Applicable

Recruiting

• Conditions: Kidney Diseases; Muscle Loss
• Interventions: Dietary Supplement: Whey protein

• Registration Number: NCT05482243
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2023-01-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise training period	Whey protein	* 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.

Primary Outcome Measures

Name	Time	Method
Muscle protein synthesis rates	1-week period	Muscle protein synthesis rates as measured by the deuterated water method

Secondary Outcome Measures

Name	Time	Method
Leg fat free mass	Baseline	as measured by DEXA
Type I and II skeletal muscle fiber size	Baseline	of muscle biopsy of vastus lateralis
Aerobic capacity	Baseline	VO2-peak test on ergometer
Physical activity levels	1-week period	as measured by accelerometry
Body composition	Baseline	as measured by BIA
Dietary intake (energy/macronutrient)	1-week period	as measured by dietary diaries
Skeletal muscle mitochondrial bioenergetics	Baseline	of muscle biopsy of vastus lateralis
Muscle strength	Baseline	1-RM max testing of leg press and leg extension

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Limburg, Netherlands