Method To Measure Protein Digestion & Absorption
Validation Of A New Method To Simultaneously Measure Protein Digestion And Absorption
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2019
CompletedFebruary 7, 2022
February 1, 2022
4.2 years
November 26, 2013
February 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
protein metabolism in gut
Digestion of the stable tracers of amino acid measured by plasma samples
In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day
Secondary Outcomes (4)
Body Composition
on screening or study day 1
Respiratory muscle strength
on study day 1
Skeletal muscle strength of hand
30 minutes on screening or study day
Skeletal muscle strength of leg
30 minutes on screening or study day
Study Arms (3)
Healthy
OTHERscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day: stable isotope infusions with blood draws, sip feed
Chronic Obstructive Pulmonary Disorder
OTHERscreening 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
Chronic Heart Failure
OTHERscreening 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
Interventions
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
Eligibility Criteria
You may not qualify if:
- 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
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas A&M University
College Station, Texas, 77843, United States
Related Publications (1)
Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
PMID: 37542951DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolaas E Deutz, PhD
Texas A&M University
- PRINCIPAL INVESTIGATOR
Marielle P Engelen, PhD
Texas A&M University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 26, 2013
First Posted
February 17, 2014
Study Start
November 1, 2014
Primary Completion
January 19, 2019
Study Completion
January 19, 2019
Last Updated
February 7, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share