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Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function

This study has been withdrawn prior to enrollment.
(Recruitment challenges)
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
ClinicalTrials.gov Identifier:
NCT01890811
First received: June 27, 2013
Last updated: April 29, 2015
Last verified: April 2015
  Purpose

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 Intervention
Chronic Kidney Failure Dietary Supplement: Boost High Protein

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function

Resource links provided by NLM:


Further study details as provided by Marielle PKJ Engelen, PhD, Texas A&M University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890811

Locations
United States, Texas
Texas A&M University
College Station, Texas, United States, 77843
Sponsors and Collaborators
Texas A&M University
  More Information

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT01890811     History of Changes
Other Study ID Numbers: 2013-0294
Study First Received: June 27, 2013
Last Updated: April 29, 2015

Keywords provided by Marielle PKJ Engelen, PhD, Texas A&M University:
CKD
Hemodialysis
Protein Digestion
Fat Digestion
Gut Function
Glucose Absorption
Muscle Function

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017