Method To Measure Protein Digestion & Absorption

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Heart Failure; Pulmonary Disorder, Chronic Obstructive	Other: sip feeding with stable isotope infusion	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Validation Of A New Method To Simultaneously Measure Protein Digestion And Absorption
Study Start Date :	November 2014
Estimated Primary Completion Date :	February 2019
Estimated Study Completion Date :	February 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
   Digestion of the stable tracers of amino acid measured by plasma samples

Secondary Outcome Measures :

1. Body Composition [ Time Frame: on screening or study day 1 ]
   Body composition as measured by Dual-Energy X-ray Absorptiometry
2. Respiratory muscle strength [ Time Frame: on study day 1 ]
   determined by measurement of maximum breathing pressures
3. Skeletal muscle strength of hand [ Time Frame: 30 minutes on screening or study day ]
   measurement of handrip strenth
4. Skeletal muscle strength of leg [ Time Frame: 30 minutes on screening or study day ]
   measurement of muscle strength of leg using kin-com machine

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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, or 20 - 30 for healthy young group

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	February 17, 2014
Last Update Posted:	March 8, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Marielle PKJ Engelen, PhD, 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