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Nutritional and Functional Changes in Heart Failure and COPD

Primary Purpose

Chronic Heart Failure, Chronic Obstructive Pulmonary Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BOOST High Protein
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring CHF, Protein digestion, Fat digestion, Gut function, Glucose absorption, Muscle function

Eligibility Criteria

20 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 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

Sites / Locations

  • Texas A&M University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boost High Protein

Arm Description

Boost high protein with added spirulina

Outcomes

Primary Outcome Measures

Net whole-body protein synthesis
change in whole-body protein synthesis rate after intake of meal

Secondary Outcome Measures

Citrulline Rate of appearance
plasma enrichment of citrulline
Glucose absorption
Recovery of 3-O-Methyl-D-glucose in the urine.
Gut permeability
recovery of rhamnose/lactulose in urine
Skeletal and respiratory muscle strength
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Cognitive function
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Fatty acid digestion after feeding
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Protein digestion after feeding
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Arginine turnover rate
Arginine enrichment in plasma
Whole body collagen breakdown rate
Hydroxyproline enrichment in plasma
Tryptophan turnover rate
Tryptophan enrichment in plasma
Insulin response to feeding
Acute change from postabsorptive state after intake of meal
Fat-free mass
Characteristics of study subjects
Myofibrillar protein breakdown rate
3methylhistidine enrichment in plasma
Glycine rate of appearance
glycine enrichment in plasma
Taurine turnover rate
enrichment of taurine in

Full Information

First Posted
February 4, 2013
Last Updated
February 3, 2022
Sponsor
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT01787682
Brief Title
Nutritional and Functional Changes in Heart Failure and COPD
Official Title
Metabolic and Functional Changes in Relation to Nutritional Status in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 17, 2017 (Actual)
Study Completion Date
September 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University

4. Oversight

Data Monitoring Committee
No

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Chronic Obstructive Pulmonary Disorder
Keywords
CHF, Protein digestion, Fat digestion, Gut function, Glucose absorption, Muscle function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boost High Protein
Arm Type
Experimental
Arm Description
Boost high protein with added spirulina
Intervention Type
Dietary Supplement
Intervention Name(s)
BOOST High Protein
Primary Outcome Measure Information:
Title
Net whole-body protein synthesis
Description
change in whole-body protein synthesis rate after intake of meal
Time Frame
0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
Secondary Outcome Measure Information:
Title
Citrulline Rate of appearance
Description
plasma enrichment of citrulline
Time Frame
Postabsorptive state during 2 hours
Title
Glucose absorption
Description
Recovery of 3-O-Methyl-D-glucose in the urine.
Time Frame
7 hours
Title
Gut permeability
Description
recovery of rhamnose/lactulose in urine
Time Frame
7 hours
Title
Skeletal and respiratory muscle strength
Description
Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Time Frame
1 day
Title
Cognitive function
Description
Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Time Frame
1 day
Title
Fatty acid digestion after feeding
Description
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Time Frame
0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Title
Protein digestion after feeding
Description
Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Time Frame
0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
Title
Arginine turnover rate
Description
Arginine enrichment in plasma
Time Frame
postabsorptive state during 3 hours
Title
Whole body collagen breakdown rate
Description
Hydroxyproline enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Tryptophan turnover rate
Description
Tryptophan enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Insulin response to feeding
Description
Acute change from postabsorptive state after intake of meal
Time Frame
during 3 hours after feeding
Title
Fat-free mass
Description
Characteristics of study subjects
Time Frame
postabsorptive state during 15 min
Title
Myofibrillar protein breakdown rate
Description
3methylhistidine enrichment in plasma
Time Frame
0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
Title
Glycine rate of appearance
Description
glycine enrichment in plasma
Time Frame
Postabsorptive state during 3 hours
Title
Taurine turnover rate
Description
enrichment of taurine in
Time Frame
postabsorptive state during 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marielle PKJ Engelen, PhD
Organizational Affiliation
Texas A&M Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M University
City
College Station
State/Province
Texas
ZIP/Postal Code
77843
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36166849
Citation
Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.
Results Reference
derived
PubMed Identifier
34743729
Citation
Pinson MR, Deutz NEP, Harrykissoon R, Zachria AJ, Engelen MPKJ. Disturbances in branched-chain amino acid profile and poor daily functioning in mildly depressed chronic obstructive pulmonary disease patients. BMC Pulm Med. 2021 Nov 7;21(1):351. doi: 10.1186/s12890-021-01719-9.
Results Reference
derived
PubMed Identifier
32035752
Citation
Engelen MPKJ, Jonker R, Thaden JJ, Ten Have GAM, Jeon MS, Dasarathy S, Deutz NEP. Comprehensive metabolic flux analysis to explain skeletal muscle weakness in COPD. Clin Nutr. 2020 Oct;39(10):3056-3065. doi: 10.1016/j.clnu.2020.01.010. Epub 2020 Jan 29.
Results Reference
derived
PubMed Identifier
28986165
Citation
Deutz NEP, Thaden JJ, Ten Have GAM, Walker DK, Engelen MPKJ. Metabolic phenotyping using kinetic measurements in young and older healthy adults. Metabolism. 2018 Jan;78:167-178. doi: 10.1016/j.metabol.2017.09.015. Epub 2017 Oct 3.
Results Reference
derived

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Nutritional and Functional Changes in Heart Failure and COPD

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