Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
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|ClinicalTrials.gov Identifier: NCT01890811|
Recruitment Status : Withdrawn (Recruitment challenges)
First Posted : July 2, 2013
Last Update Posted : May 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Failure||Dietary Supplement: Boost High Protein||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Experimental: Boost High Protein
Boost high protein with added spirulina
Dietary Supplement: Boost High Protein
Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.
- 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
- Citrulline Rate of appearance [ Time Frame: Postabsorptive state during 3 hours ]Plasma enrichment of citrulline
- Glucose absorption [ Time Frame: 7 hours ]Recovery of 3-O-Methyl-D-glucose in the urine.
- Gut permeability [ Time Frame: 7 hours ]Recovery of rhamnose/lactulose in urine
- 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.
- Cognitive function [ Time Frame: 1 day ]Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
- Fatty acid digestion after feeding [ Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal ]Enrichment in palmitic acid and tripalmitin fatty acids in plasma
- 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
- Arginine turnover rate [ Time Frame: Postabsorptive state during 3 hours ]Arginine enrichment in plasma
- Whole body collagen breakdown rate [ Time Frame: Postabsorptive state during 3 hours ]Hydroxyproline enrichment in plasma
- Tryptophan turnover rate [ Time Frame: Postabsorptive state during 3 hours ]Tryptophan enrichment in plasma
- Insulin response to feeding [ Time Frame: During 3 hours after feeding ]Acute change from postabsorptive state after intake of meal
- Fat-free mass [ Time Frame: Postabsorptive state during 15 min ]Characteristics of study subjects
- Myofibrillar protein breakdown rate [ Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal ]3-Methylhistidine enrichment in plasma
- Glycine rate of appearance [ Time Frame: Postabsorptive state during 3 hours ]Glycine enrichment in plasma
- Taurine turnover rate [ Time Frame: Postabsorptive state during 3 hours ]Enrichment of taurine in plasma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890811
|United States, Texas|
|Texas A&M University|
|College Station, Texas, United States, 77843|