We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01890811
Recruitment Status : Withdrawn (Recruitment challenges)
First Posted : July 2, 2013
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Tracking Information
First Submitted Date  ICMJE June 27, 2013
First Posted Date  ICMJE July 2, 2013
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
Official Title  ICMJE Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Kidney Failure
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Boost High Protein
Boost high protein with added spirulina
Intervention: Dietary Supplement: Boost High Protein
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 29, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
46
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01890811
Other Study ID Numbers  ICMJE 2013-0294
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Marielle PKJ Engelen, PhD, Texas A&M University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Texas A&M University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Texas A&M University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP