Back to resultsChronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
Primary Purpose
Chronic Kidney Failure
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boost High Protein
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Failure focused on measuring CKD, Hemodialysis, Protein Digestion, Fat Digestion, Gut Function, Glucose Absorption, Muscle Function
Eligibility Criteria
Inclusion criteria CKD subjects
- Ability to walk, sit down and stand up independently
- Age 55 years or older
- Ability to lie in supine or elevated position for 7 hours
- Diagnosis of kidney disease; undergoing hemodialysis
- Clinically stable condition; no hospitalization 4 weeks preceding first study day
- Willingness and ability to comply with the protocol
Inclusion criteria healthy subjects:
- Healthy male or female according to the investigator's or appointed staff's judgment
- Ability to walk, sit down and stand up independently
- Age 55 years or older (older control group)
- Ability to lay in supine or elevated position for 7 hours
- No diagnosis of CKD
- Willingness and ability to comply with the protocol
Exclusion Criteria all subjects:
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Body mass index >40 kg/m2 (healthy subjects only)
- Any other condition that would interfere with the study or safety of the patient (according to the PI or nurse)
- Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- Use of long-term oral corticosteroids or short course of oral corticosteroids within 4 weeks preceding first study day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- (Possible) pregnancy
Sites / Locations
- Texas A&M University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Boost High Protein
Arm Description
Boost high protein with added spirulina
Outcomes
Primary Outcome Measures
Net whole-body protein synthesis
Change in whole-body protein synthesis rate after intake of meal
Secondary Outcome Measures
Citrulline Rate of appearance
Plasma enrichment of citrulline
Glucose absorption
Recovery of 3-O-Methyl-D-glucose in the urine.
Gut permeability
Recovery of rhamnose/lactulose in urine
Skeletal and respiratory muscle strength
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Cognitive function
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Fatty acid digestion after feeding
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Protein digestion after feeding
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Arginine turnover rate
Arginine enrichment in plasma
Whole body collagen breakdown rate
Hydroxyproline enrichment in plasma
Tryptophan turnover rate
Tryptophan enrichment in plasma
Insulin response to feeding
Acute change from postabsorptive state after intake of meal
Fat-free mass
Characteristics of study subjects
Myofibrillar protein breakdown rate
3-Methylhistidine enrichment in plasma
Glycine rate of appearance
Glycine enrichment in plasma
Taurine turnover rate
Enrichment of taurine in plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01890811
Brief Title
Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
Official Title
Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment challenges
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. Attempts to reverse weight and muscle loss in CKD and improve nutritional status by nutritional supplementation have been unsuccessful and there are currently no approved therapies.
Purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CKD patients compared to matched healthy controls. Additionally, to examine whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy controls. This will provide required information that will lead to implement new strategies to develop optimal nutritional regimen in order to enhance nutritional status, quality of life and survival in relation to kidney disease.
Detailed Description
This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7.5 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure
Keywords
CKD, Hemodialysis, Protein Digestion, Fat Digestion, Gut Function, Glucose Absorption, Muscle Function
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Boost High Protein
Arm Type
Experimental
Arm Description
Boost high protein with added spirulina
Intervention Type
Dietary Supplement
Intervention Name(s)
Boost High Protein
Intervention Description
Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.
Primary Outcome Measure Information:
Title
Net whole-body protein synthesis
Description
Change in whole-body protein synthesis rate after intake of meal
Time Frame
0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
Secondary Outcome Measure Information:
Title
Citrulline Rate of appearance
Description
Plasma enrichment of citrulline
Time Frame
Postabsorptive state during 3 hours
Title
Glucose absorption
Description
Recovery of 3-O-Methyl-D-glucose in the urine.
Time Frame
7 hours
Title
Gut permeability
Description
Recovery of rhamnose/lactulose in urine
Time Frame
7 hours
Title
Skeletal and respiratory muscle strength
Description
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Time Frame
1 day
Title
Cognitive function
Description
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Time Frame
1 day
Title
Fatty acid digestion after feeding
Description
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Time Frame
0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Title
Protein digestion after feeding
Description
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Time Frame
0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
Title
Arginine turnover rate
Description
Arginine enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Whole body collagen breakdown rate
Description
Hydroxyproline enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Tryptophan turnover rate
Description
Tryptophan enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Insulin response to feeding
Description
Acute change from postabsorptive state after intake of meal
Time Frame
During 3 hours after feeding
Title
Fat-free mass
Description
Characteristics of study subjects
Time Frame
Postabsorptive state during 15 min
Title
Myofibrillar protein breakdown rate
Description
3-Methylhistidine enrichment in plasma
Time Frame
0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Title
Glycine rate of appearance
Description
Glycine enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Taurine turnover rate
Description
Enrichment of taurine in plasma
Time Frame
Postabsorptive state during 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria CKD subjects
Ability to walk, sit down and stand up independently
Age 55 years or older
Ability to lie in supine or elevated position for 7 hours
Diagnosis of kidney disease; undergoing hemodialysis
Clinically stable condition; no hospitalization 4 weeks preceding first study day
Willingness and ability to comply with the protocol
Inclusion criteria healthy subjects:
Healthy male or female according to the investigator's or appointed staff's judgment
Ability to walk, sit down and stand up independently
Age 55 years or older (older control group)
Ability to lay in supine or elevated position for 7 hours
No diagnosis of CKD
Willingness and ability to comply with the protocol
Exclusion Criteria all subjects:
Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
Established diagnosis of malignancy
Established diagnosis of Insulin Dependent Diabetes Mellitus
History of untreated metabolic diseases including hepatic disorder
Presence of acute illness or metabolically unstable chronic illness
Presence of fever within the last 3 days
Body mass index >40 kg/m2 (healthy subjects only)
Any other condition that would interfere with the study or safety of the patient (according to the PI or nurse)
Use of protein or amino acid containing nutritional supplements within 5 days of first study day
Use of long-term oral corticosteroids or short course of oral corticosteroids within 4 weeks preceding first study day
Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
(Possible) pregnancy
Facility Information:
Facility Name
Texas A&M University
City
College Station
State/Province
Texas
ZIP/Postal Code
77843
Country
United States
12. IPD Sharing Statement
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Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
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