CHF COPD Sip Feed Anabolic Response

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-10

Study Completion Date

2018-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive Congestive Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing

Group Type EXPERIMENTAL

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.

study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing

Group Type EXPERIMENTAL

sip feeding with stable isotope infusion

Intervention Type OTHER

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

Congestive Heart Failure

screening visit: body weight and composition by DXA, height, and vital signs will be assessed.

study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing

Group Type EXPERIMENTAL

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 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

* 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 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

* 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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes