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CHF COPD Sip Feed Anabolic Response

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ClinicalTrials.gov Identifier: NCT02770092
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE May 12, 2016
Last Update Posted Date April 11, 2019
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
Change in net whole-body protein synthesis [ 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
  • Body Composition [ Time Frame: 15 minutes on screening or study day 1 ]
    Body composition as measured by Dual-Energy X-ray Absorptiometry
  • Skeletal muscle strength [ Time Frame: on study day 1 ]
    handgrip and kin-com 1-leg test
  • Respiratory muscle strength [ Time Frame: on study day 1 ]
    Maximum inhalation and exhalation pressure
  • Gut function [ 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
  • Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS) [ 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.
  • Executive Function-Adolescent/Adult Sensory Profile (ASP): [ 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.
  • Group differences in quality of life as measured by Short Form (36) Health Survey (SF36) [ 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).
  • Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE) [ 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.
  • Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT), [ 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.
  • Group differences in state of mood as measured by the Profile of Mood State (POMS) [ 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.
  • Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT), [ 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.
  • Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT) [ 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.
  • Group differences in attention and executive functions as measured by PASAT [ 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.
  • Group differences in attention and executive functions as measured by Trail Making Test (TMT) [ 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.
  • Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA) [ 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.
  • Group differences in attention and executive functions as measured by Brief-A [ 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.
  • diet recall [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHF COPD Sip Feed Anabolic Response
Official Title  ICMJE Anabolic Responsiveness to Protein Intake in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Congestive Heart Failure
Intervention  ICMJE Other: sip feeding with stable isotope infusion
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
Study Arms  ICMJE
  • Experimental: 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

    Intervention: Other: sip feeding with stable isotope infusion
  • Experimental: 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

    Intervention: Other: sip feeding with stable isotope infusion
  • Experimental: 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

    Intervention: Other: sip feeding with stable isotope infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marielle Engelen, PhD 9792202282 mpkj.engelen@ctral.org
Contact: Agata McNew, M.Sc.Eng 979.583.5800 a.wierzchowska@ctral.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02770092
Other Study ID Numbers  ICMJE IRB2015-0676
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marielle PKJ Engelen, PhD, Texas A&M University
Study Sponsor  ICMJE Texas A&M University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marielle Engelen Study Principal Investigator
PRS Account Texas A&M University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP