- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787682
Nutritional and Functional Changes in Heart Failure and COPD
February 3, 2022 updated by: Marielle PKJ Engelen, PhD, Texas A&M University
Metabolic and Functional Changes in Relation to Nutritional Status in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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College Station, Texas, United States, 77843
- Texas A&M University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Boost High Protein
Boost high protein with added spirulina
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net whole-body protein synthesis
Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
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change in whole-body protein synthesis rate after intake of meal
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0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Citrulline Rate of appearance
Time Frame: Postabsorptive state during 2 hours
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plasma enrichment of citrulline
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Postabsorptive state during 2 hours
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Glucose absorption
Time Frame: 7 hours
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Recovery of 3-O-Methyl-D-glucose in the urine.
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7 hours
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Gut permeability
Time Frame: 7 hours
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recovery of rhamnose/lactulose in urine
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7 hours
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Skeletal and respiratory muscle strength
Time Frame: 1 day
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Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
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1 day
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Cognitive function
Time Frame: 1 day
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Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
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1 day
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Fatty acid digestion after feeding
Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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Enrichment in palmitic acid and tripalmitin fatty acids in plasma
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0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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Protein digestion after feeding
Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
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Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
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0,15,30,45,60,75,90,105,120,150,180,210, min post-meal
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Arginine turnover rate
Time Frame: postabsorptive state during 3 hours
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Arginine enrichment in plasma
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postabsorptive state during 3 hours
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Whole body collagen breakdown rate
Time Frame: Postabsorptive state during 3 hours
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Hydroxyproline enrichment in plasma
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Postabsorptive state during 3 hours
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Tryptophan turnover rate
Time Frame: Postabsorptive state during 3 hours
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Tryptophan enrichment in plasma
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Postabsorptive state during 3 hours
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Insulin response to feeding
Time Frame: during 3 hours after feeding
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Acute change from postabsorptive state after intake of meal
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during 3 hours after feeding
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Fat-free mass
Time Frame: postabsorptive state during 15 min
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Characteristics of study subjects
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postabsorptive state during 15 min
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Myofibrillar protein breakdown rate
Time Frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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3methylhistidine enrichment in plasma
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0,15,30,45,60,75,90,105,120,150,180,210 min post-meal
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Glycine rate of appearance
Time Frame: Postabsorptive state during 3 hours
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glycine enrichment in plasma
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Postabsorptive state during 3 hours
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Taurine turnover rate
Time Frame: postabsorptive state during 3 hours
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enrichment of taurine in
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postabsorptive state during 3 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marielle PKJ Engelen, PhD, Texas A&M Univeristy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 Sep 27. pii: nqac277. doi: 10.1093/ajcn/nqac277. [Epub ahead of print]
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
September 17, 2017
Study Completion (Actual)
September 17, 2017
Study Registration Dates
First Submitted
February 4, 2013
First Submitted That Met QC Criteria
February 6, 2013
First Posted (Estimate)
February 11, 2013
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 3, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-0503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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