Back to results

CHF COPD Sip Feed Anabolic Response

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Congestive Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

sip feeding with stable isotope infusion

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Texas A&M University-CTRALRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Healthy

Chronic Obstructive Pulmonary Disorder

Congestive Heart Failure

Arm Description

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

Outcomes

Primary Outcome Measures

Change in net whole-body protein synthesis

Change in whole-body protein synthesis rate after intake of meal

Secondary Outcome Measures

Body Composition

Body composition as measured by Dual-Energy X-ray Absorptiometry

Skeletal muscle strength

handgrip and kin-com 1-leg test

Respiratory muscle strength

Maximum inhalation and exhalation pressure

Gut function

Digestion of the stable tracers of amino acid

Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)

a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.

Executive Function-Adolescent/Adult Sensory Profile (ASP):

a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.

Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)

self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT).

Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)

questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.

Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),

a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.

Group differences in state of mood as measured by the Profile of Mood State (POMS)

A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.

Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),

The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total and mean words recorded across the three trials) was reported.

Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)

a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information.

Group differences in attention and executive functions as measured by PASAT

a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.

Group differences in attention and executive functions as measured by Trail Making Test (TMT)

n Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.

Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)

assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.

Group differences in attention and executive functions as measured by Brief-A

a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.

diet recall

The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.

Full Information

NCT ID

NCT02770092

First Posted

May 5, 2016

Last Updated

April 10, 2019

Sponsor

Texas A&M University

1. Study Identification

Unique Protocol Identification Number

NCT02770092

Brief Title

CHF COPD Sip Feed Anabolic Response

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

February 2020 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas A&M University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive, Congestive Heart Failure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy

Arm Type

Experimental

Arm Description

Arm Title

Chronic Obstructive Pulmonary Disorder

Arm Type

Experimental

Arm Description

Arm Title

Congestive Heart Failure

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

sip feeding with stable isotope infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in net whole-body protein synthesis

Description

Change in whole-body protein synthesis rate after intake of meal

Time Frame

0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min

Secondary Outcome Measure Information:

Title

Body Composition

Description

Body composition as measured by Dual-Energy X-ray Absorptiometry

Time Frame

15 minutes on screening or study day 1

Title

Skeletal muscle strength

Description

handgrip and kin-com 1-leg test

Time Frame

on study day 1

Title

Respiratory muscle strength

Description

Maximum inhalation and exhalation pressure

Time Frame

on study day 1

Title

Gut function

Description

Digestion of the stable tracers of amino acid

Time Frame

In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day

Title

Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)

Description

Time Frame