Nutritional and Functional Changes in Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Texas A&M University
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
ClinicalTrials.gov Identifier:
NCT01787682
First received: February 4, 2013
Last updated: May 17, 2016
Last verified: May 2016
  Purpose
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 cross-sectional 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. The hypothesis is that CHF and COPD are related to decreased gut function and absorption, leading to decreased anabolic response. Second, this decreased nutritional status is linked to reduced muscle functioning and possibly decreased cognition. In addition, we will examine the effect of aging on by comparing gut function digestion and absorption of the CHF and COPD aged matched healthy controls to a group of young healthy subjects.

Condition Intervention
Chronic Heart Failure
Chronic Obstructive Pulmonary Disorder
Dietary Supplement: BOOST High Protein

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Metabolic and Functional Changes in Relation to Nutritional Status in Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Texas A&M University:

Primary Outcome Measures:
  • Net whole-body protein synthesis [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal ] [ Designated as safety issue: No ]
    change in whole-body protein synthesis rate after intake of meal


Secondary Outcome Measures:
  • Citrulline Rate of appearance [ Time Frame: Postabsorptive state during 2 hours ] [ Designated as safety issue: No ]
    plasma enrichment of citrulline

  • Glucose absorption [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Recovery of 3-O-Methyl-D-glucose in the urine.

  • Gut permeability [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    recovery of rhamnose/lactulose in urine

  • Skeletal and respiratory muscle strength [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.

  • Cognitive function [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism

  • Fatty acid digestion after feeding [ Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal ] [ Designated as safety issue: No ]
    Enrichment in palmitic acid and tripalmitin fatty acids in plasma

  • Protein digestion after feeding [ Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal ] [ Designated as safety issue: No ]
    Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina

  • Arginine turnover rate [ Time Frame: postabsorptive state during 3 hours ] [ Designated as safety issue: No ]
    Arginine enrichment in plasma

  • Whole body collagen breakdown rate [ Time Frame: Postabsorptive state during 3 hours ] [ Designated as safety issue: No ]
    Hydroxyproline enrichment in plasma

  • Tryptophan turnover rate [ Time Frame: Postabsorptive state during 3 hours ] [ Designated as safety issue: No ]
    Tryptophan enrichment in plasma

  • Insulin response to feeding [ Time Frame: during 3 hours after feeding ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of meal

  • Fat-free mass [ Time Frame: postabsorptive state during 15 min ] [ Designated as safety issue: No ]
    Characteristics of study subjects

  • Myofibrillar protein breakdown rate [ Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal ] [ Designated as safety issue: No ]
    3methylhistidine enrichment in plasma

  • Glycine rate of appearance [ Time Frame: Postabsorptive state during 3 hours ] [ Designated as safety issue: No ]
    glycine enrichment in plasma

  • Taurine turnover rate [ Time Frame: postabsorptive state during 3 hours ] [ Designated as safety issue: No ]
    enrichment of taurine in


Estimated Enrollment: 105
Study Start Date: December 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boost High Protein
Boost high protein with added spirulina
Dietary Supplement: BOOST High Protein

Detailed Description:
This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7 hours.
  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 7 hours
  • Diagnosis of Chronic Heart Failure; under regular care by cardiologist
  • NYHA class II-IV
  • Reduced ejection fraction (<45%) assessed in the past 2 years
  • 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 control 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 7 hours
  • No diagnosis of CHF
  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787682

Contacts
Contact: Marielle PKJ Engelen, PhD 979-2202282 mpkj.engelen@ctral.org
Contact: Fari T Koeman 9792195505 f.koeman@ctral.org

Locations
United States, Texas
Texas A&M University Recruiting
College Station, Texas, United States, 77843
Contact: Marielle PKJ Engelen, PhD    9792202282    mpkj.engelen@ctral.org   
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Marielle PKJ Engelen, PhD Texas A&M Univeristy
  More Information

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT01787682     History of Changes
Other Study ID Numbers: 2012-0503 
Study First Received: February 4, 2013
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Texas A&M University:
CHF
Protein digestion
Fat digestion
Gut function
Glucose absorption
Muscle function

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 29, 2016