Method To Measure Protein Digestion & Absorption (NCT02065141) | Clinical Trial Compass
CompletedNot Applicable
Method To Measure Protein Digestion & Absorption
United States74 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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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…
What they're measuring
1
protein metabolism in gut
Timeframe: In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day