Method To Measure Protein Digestion & Absorption
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ClinicalTrials.gov Identifier: NCT02065141 |
Recruitment Status :
Recruiting
First Posted : February 17, 2014
Last Update Posted : March 8, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Heart Failure Pulmonary Disorder, Chronic Obstructive | Other: sip feeding with stable isotope infusion | Not Applicable |
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 |
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 |
- 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
- Body Composition [ Time Frame: on screening or study day 1 ]Body composition as measured by Dual-Energy X-ray Absorptiometry
- Respiratory muscle strength [ Time Frame: on study day 1 ]determined by measurement of maximum breathing pressures
- Skeletal muscle strength of hand [ Time Frame: 30 minutes on screening or study day ]measurement of handrip strenth
- Skeletal muscle strength of leg [ Time Frame: 30 minutes on screening or study day ]measurement of muscle strength of leg using kin-com machine

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065141
Contact: Marielle P Engelen, PhD | 9792202282 | mpkj.engelen@ctral.org | |
Contact: Agata C McNew, M.Sc.Eng | 979.583.5800 | a.wierzchowska@ctral.org |
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. |
Principal Investigator: | Nicolaas E Deutz, PhD | Texas A&M University | |
Principal Investigator: | Marielle P Engelen, PhD | Texas A&M University |
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 Key Record Dates |
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 |