Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
- Conditions
- Chronic Kidney Failure
- Interventions
- Dietary Supplement: Boost High Protein
- Registration Number
- NCT01890811
- Lead Sponsor
- Texas A&M University
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Boost High Protein Boost High Protein Boost high protein with added spirulina
- Primary Outcome Measures
Name Time Method Net whole-body protein synthesis 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
- Secondary Outcome Measures
Name Time Method Cognitive function 1 day Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Tryptophan turnover rate Postabsorptive state during 3 hours Tryptophan enrichment in plasma
Myofibrillar protein breakdown rate 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal 3-Methylhistidine enrichment in plasma
Glycine rate of appearance Postabsorptive state during 3 hours Glycine enrichment in plasma
Skeletal and respiratory muscle strength 1 day Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Glucose absorption 7 hours Recovery of 3-O-Methyl-D-glucose in the urine.
Gut permeability 7 hours Recovery of rhamnose/lactulose in urine
Citrulline Rate of appearance Postabsorptive state during 3 hours Plasma enrichment of citrulline
Fatty acid digestion after feeding 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 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Insulin response to feeding During 3 hours after feeding Acute change from postabsorptive state after intake of meal
Arginine turnover rate Postabsorptive state during 3 hours Arginine enrichment in plasma
Whole body collagen breakdown rate Postabsorptive state during 3 hours Hydroxyproline enrichment in plasma
Fat-free mass Postabsorptive state during 15 min Characteristics of study subjects
Taurine turnover rate Postabsorptive state during 3 hours Enrichment of taurine in plasma
Trial Locations
- Locations (1)
Texas A&M University
🇺🇸College Station, Texas, United States