Texas A&M University-CTRAL
College Station, Texas, 77843, United States
NCT Number: NCT02770092
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.
Looking for future studies?
Notify Me45 year and older
All sexes
Interventional
Not applicable
College Station, Texas, 77843, United States
General aims:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
CHF subjects:
Inclusion criteria
COPD subjects:
Inclusion criteria
healthy subjects:
Exclusion criteria
all subjects:
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.
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
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
Change in whole-body protein synthesis rate after intake of meal
Time frame: 15 minutes on screening or study day 1
Body composition as measured by Dual-Energy X-ray Absorptiometry
Time frame: on study day 1
handgrip and kin-com 1-leg test
Time frame: on study day 1
Maximum inhalation and exhalation pressure
Time frame: In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day
Digestion of the stable tracers of amino acid
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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).
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
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.
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
Time frame: on study day 1
The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.
Texas A&M University
Other
Anabolic Responsiveness to Protein Intake in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06890208
Anxiety Disorders, Arrhythmias, Cardiac
Hamburg, Germany
View Trial DetailsNCT04283994
Brain Diseases, Cardiovascular Diseases
Seattle, Washington, United States
View Trial DetailsNCT04281784
Brain Diseases, Cardiovascular Diseases
Seattle, Washington, United States
View Trial DetailsNCT05168722
Behavior, Behavioral Symptoms
Vitoria-Gasteiz, Alava, Spain
View Trial Details