Protein and Exercise Training in Chronic KIDNEY Disease

NCT05482243 | Completed DMC

• 1 other identifier: METC 22-032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases; Muscle Loss

Outcome Measures

Primary Outcomes (1)

• Muscle protein synthesis rates

  Muscle protein synthesis rates as measured by the deuterated water method

  1-week period

Secondary Outcomes (8)

• Physical activity levels

  1-week period

• Dietary intake (energy/macronutrient)

  1-week period

• Leg fat free mass

  Baseline

• Body composition

  Baseline

• Type I and II skeletal muscle fiber size

  Baseline

Study Arms (2)

Habitual lifestyle period

NO 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 period

EXPERIMENTAL

* 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.

Dietary Supplement: Whey protein

Interventions

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.

Also known as: Resistance exercise

Exercise training period

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Kidney Diseases; Muscular Atrophy

Interventions

Whey Proteins; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luc JC van Loon, Prof. Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to either start with the habitual lifestyle period or the exercise training period. All randomization procedures will be executed by an independent researcher. Due to the nature of the intervention, blinding of participants and investigators during the exercise training period is not possible. During the analysis, the research technicians will only receive the participant codes to ensure blinding during analysis of blood, saliva, and muscle 2H-enrichment. Thereafter, an independent researcher will provided a blinded dataset to the research team.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover study (1-week intervention vs. 1-week habitual lifestyle) for both patients with advanced CKD and healthy controls

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: January 1, 2023
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

NL (1)