CHF COPD Sip Feed Anabolic Response



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:45 - Any
Updated:4/17/2018
Start Date:February 2016
End Date:February 2020
Contact:Marielle Engelen, PhD
Email:mpkj.engelen@ctral.org
Phone:9792202282

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Anabolic Responsiveness to Protein Intake in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder

Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic
obstructive pulmonary disorder (COPD), negatively influencing their quality of life,
treatment response and survival. Loss of muscle protein is generally a central component of
weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone
density, independent of the severity of the disease state. The purpose of this study is to
provide detailed insight in disease related gut function by obtaining information on gut
permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients
compared to matched healthy controls. This will provide required information that is
necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD.

General aims:

- To study the whole-body protein anabolic effect of several dosages of a high-quality
protein sip feeding in COPD and CHF subjects as compared to healthy controls.

- To investigate the anabolic threshold in subjects with COPD and CHF as compared to
healthy controls.

Purpose and objectives: Although the Researchers' previous study supports the concept of
supplementing high-quality milk proteins in chronic wasting diseases i.e., COPD and CHF, the
dose-response anabolic effects of proteins with high EAA levels are still unclear.
Furthermore, there is no insight in the actual protein requirements in COPD and CHF. The
knowledge gained from this study will benefit insight in terms of promotion of protein gain
after feeding in COPD and CHF subjects. Based on the obtained data of protein behavior
(protein kinetics) the Researchers will be able to further refine and personalize nutritional
supplementation in COPD and CHF subjects in order to stop and even restore progressive muscle
wasting.

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 8 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 or female according to the investigator's or appointed staff's judgment

- Ability to walk, sit down and stand up independently

- Age 45 years or older (older control group)

- Age between 20-30 years old (young group)

- Ability to lay in supine or elevated position for 8 hours

- No diagnosis of CHF or COPD

- Willingness and ability to comply with the protocol

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 of 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

When during the period from enrollment to the test day any condition causing the subject to
not meet inclusion criteria or to meet exclusion criteria, the subject will be excluded
from the study.
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College Station, Texas 77845
Phone: 979-220-2282
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