Method To Measure Protein Digestion & Absorption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-01-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Heart Failure Pulmonary Disorder, Chronic Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

sip feeding with stable isotope infusion

Intervention Type OTHER

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

Group Type OTHER

sip feeding with stable isotope infusion

Intervention Type OTHER

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

Group Type OTHER

sip feeding with stable isotope infusion

Intervention Type OTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Interventions

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sip feeding with stable isotope infusion

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes