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Protein and Exercise Training in Chronic KIDNEY Disease (PET KIDNEY)

Primary Purpose

Kidney Diseases, Muscle Loss

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Whey protein
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

  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.

Sites / Locations

  • Maastricht University Medical Center+Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Habitual lifestyle period

Exercise training period

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Muscle protein synthesis rates
Muscle protein synthesis rates as measured by the deuterated water method

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2022
Last Updated
March 28, 2023
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05482243
Brief Title
Protein and Exercise Training in Chronic KIDNEY Disease
Acronym
PET KIDNEY
Official Title
Protein Supplementation and Exercise Training to Increase Muscle Protein Synthesis Rates in Patients With Advanced Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Muscle Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover study (1-week intervention vs. 1-week habitual lifestyle) for both patients with advanced CKD and healthy controls
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Habitual lifestyle period
Arm Type
No Intervention
Arm Description
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
Arm Title
Exercise training period
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Other Intervention Name(s)
Resistance exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle protein synthesis rates
Description
Muscle protein synthesis rates as measured by the deuterated water method
Time Frame
1-week period
Secondary Outcome Measure Information:
Title
Physical activity levels
Description
as measured by accelerometry
Time Frame
1-week period
Title
Dietary intake (energy/macronutrient)
Description
as measured by dietary diaries
Time Frame
1-week period
Title
Leg fat free mass
Description
as measured by DEXA
Time Frame
Baseline
Title
Body composition
Description
as measured by BIA
Time Frame
Baseline
Title
Type I and II skeletal muscle fiber size
Description
of muscle biopsy of vastus lateralis
Time Frame
Baseline
Title
Skeletal muscle mitochondrial bioenergetics
Description
of muscle biopsy of vastus lateralis
Time Frame
Baseline
Title
Muscle strength
Description
1-RM max testing of leg press and leg extension
Time Frame
Baseline
Title
Aerobic capacity
Description
VO2-peak test on ergometer
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Floris K Hendriks, M.D.
Phone
+31655522347
Email
f.hendriks@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Luc JC van Loon, Prof. Dr.
Phone
+31 43 388 1397
Email
l.vanloon@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, Prof. Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
Phone
0031433881810
Email
l.vanloon@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Luc van Loon, PhD
First Name & Middle Initial & Last Name & Degree
Floris Hendriks, MD
First Name & Middle Initial & Last Name & Degree
Dion Houtvast, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet determined

Learn more about this trial

Protein and Exercise Training in Chronic KIDNEY Disease

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