Method To Measure Protein Digestion & Absorption

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Texas A&M University
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
ClinicalTrials.gov Identifier:
NCT02065141
First received: November 26, 2013
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
The aim of the present study is to validate a new method in healthy volunteers and those diagnosed with COPD and CHF that is able to measure protein digestion and absorption simultaneously. This method is used to quantify digestion and absorption in patients who are suspect of impaired digestion and absorption resulting in loss of nutrients.Findings may be used to develop treatment strategies to improve protein digestion and absorption in these patient groups.

Condition Intervention
Chronic Heart Failure
Pulmonary Disorder, Chronic Obstructive
Other: sip feeding with stable isotope infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Validation Of A New Method To Simultaneously Measure Protein Digestion And Absorption

Resource links provided by NLM:


Further study details as provided by Texas A&M University:

Primary Outcome Measures:
  • protein metabolism in gut [ Time Frame: In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day ] [ Designated as safety issue: No ]
    Digestion of the stable tracers of amino acid measured by plasma samples


Secondary Outcome Measures:
  • Body Composition [ Time Frame: on screening or study day 1 ] [ Designated as safety issue: No ]
    Body composition as measured by Dual-Energy X-ray Absorptiometry

  • Respiratory muscle strength [ Time Frame: on study day 1 ] [ Designated as safety issue: No ]
    determined by measurement of maximum breathing pressures

  • Skeletal muscle strength of hand [ Time Frame: 30 minutes on screening or study day ] [ Designated as safety issue: No ]
    measurement of handrip strenth

  • Skeletal muscle strength of leg [ Time Frame: 30 minutes on screening or study day ] [ Designated as safety issue: No ]
    measurement of muscle strength of leg using kin-com machine


Estimated Enrollment: 90
Study Start Date: November 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy

screening visit: body weight and composition by DXA, height, and vital signs will be assessed.

study day: stable isotope infusions with blood draws, sip feed

Other: sip feeding with stable isotope infusion
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
Chronic Obstructive Pulmonary Disorder

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical information about them that will help determine study eligibility or can be used for later coding.

study day: stable isotope infusions with blood draws, sip feed

Other: sip feeding with stable isotope infusion
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
Chronic Heart Failure

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical information about them that will help determine study eligibility or can be used for later coding.

study day: stable isotope infusions with blood draws, sip feed

Other: sip feeding with stable isotope infusion
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Detailed Description:
The study involves 1 screening visit of approximately 1-2 hours and 1 test day of approximately 8 hours. On the study day protein digestion and absorption will be measured using a mixture of amino acids that are made slightly heavier than normal, called stable isotopes. Subjects will receive feeding by sips to monitor changes in digestion and absorption, which can be picked up by stable isotope technology.
  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

IInclusion and exclusion criteria for study participation:

We will enroll subjects (males and females of all races) based on the inclusion/exclusion criteria described below. All subjects should be able to walk, sit and stand up indepedently. Screening procedures will be done prior to the study.

Inclusion criteria - CHF subjects:

  • Ability to walk, sit down and stand up independently
  • Age 45 years or older
  • Ability to lie in supine or elevated position for 9 hours
  • Diagnosis of CHF; under regular care by cardiologist
  • Reduced ejection fraction (<45%) assessed in the past 2 years
  • NYHA class II-IV
  • Clinically stable condition; no hospitalization 4 weeks preceding first study day
  • Willingness and ability to comply with the protocol

Inclusion criteria - COPD subjects:

  • Ability to walk, sit down and stand up independently
  • Age 45 years or older
  • Ability to lie in supine or elevated position for 8 hours
  • Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 < 70% of reference FEV1
  • Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
  • Shortness of breath on exertion
  • Willingness and ability to comply with the protocol

Inclusion criteria - healthy subjects:

  • Healthy male & female according to the investigator's or appointed staff's judgment
  • Age 45 years and older

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
  • History of untreated metabolic diseases including hepatic or renal 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 according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
  • Use of protein or amino acid containing nutritional supplements within 5 days prior first study day
  • Current Use of long-term oral corticosteroids (CHF only)
  • Use of 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
  • Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
  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: NCT02065141

Contacts
Contact: Marielle P Engelen, PhD 9792202282 mpkj.engelen@ctral.org
Contact: Agata C McNew, M.Sc.Eng 979.583.5800 a.wierzchowska@ctral.org

Locations
United States, Texas
Texas A&M University Recruiting
College Station, Texas, United States, 77843
Contact: Marielle P Engelen, Ph.D.    979-220-2282    mpkj.engelen@ctral.org   
Contact: Agata McNew, M.Sc.Eng    .979.583.5800    a.wierzchowska@ctral.org   
Principal Investigator: Marielle Engelen, Ph.D.         
Principal Investigator: Nicolaas E Deutz, Ph.D.         
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Nicolaas E Deutz, PhD Texas A&M University
Principal Investigator: Marielle P Engelen, PhD Texas A&M University
  More Information

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT02065141     History of Changes
Other Study ID Numbers: 2013-0758F 
Study First Received: November 26, 2013
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Texas A&M University:
digestion
absorption
protein
amino acids
heart failure
COPD

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 25, 2016