- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890811
Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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College Station, Texas, United States, 77843
- Texas A&M University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Boost High Protein
Boost high protein with added spirulina
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Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net whole-body protein synthesis
Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
|
Change in whole-body protein synthesis rate after intake of meal
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0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose absorption
Time Frame: 7 hours
|
Recovery of 3-O-Methyl-D-glucose in the urine.
|
7 hours
|
Skeletal and respiratory muscle strength
Time Frame: 1 day
|
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
|
1 day
|
Cognitive function
Time Frame: 1 day
|
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
|
1 day
|
Fatty acid digestion after feeding
Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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Enrichment in palmitic acid and tripalmitin fatty acids in plasma
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0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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Protein digestion after feeding
Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
|
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
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0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
|
Whole body collagen breakdown rate
Time Frame: Postabsorptive state during 3 hours
|
Hydroxyproline enrichment in plasma
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Postabsorptive state during 3 hours
|
Tryptophan turnover rate
Time Frame: Postabsorptive state during 3 hours
|
Tryptophan enrichment in plasma
|
Postabsorptive state during 3 hours
|
Arginine turnover rate
Time Frame: Postabsorptive state during 3 hours
|
Arginine enrichment in plasma
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Postabsorptive state during 3 hours
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Insulin response to feeding
Time Frame: During 3 hours after feeding
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Acute change from postabsorptive state after intake of meal
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During 3 hours after feeding
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Fat-free mass
Time Frame: Postabsorptive state during 15 min
|
Characteristics of study subjects
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Postabsorptive state during 15 min
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Glycine rate of appearance
Time Frame: Postabsorptive state during 3 hours
|
Glycine enrichment in plasma
|
Postabsorptive state during 3 hours
|
Taurine turnover rate
Time Frame: Postabsorptive state during 3 hours
|
Enrichment of taurine in plasma
|
Postabsorptive state during 3 hours
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Citrulline Rate of appearance
Time Frame: Postabsorptive state during 3 hours
|
Plasma enrichment of citrulline
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Postabsorptive state during 3 hours
|
Gut permeability
Time Frame: 7 hours
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Recovery of rhamnose/lactulose in urine
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7 hours
|
Myofibrillar protein breakdown rate
Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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3-Methylhistidine enrichment in plasma
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0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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