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Completed

NCT Number: NCT01787682

Nutritional and Functional Changes in Heart Failure and COPD

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M University

College Station, Texas, 77843, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOOST High Protein

Dietary Supplement

Primary outcomes

  1. Net whole-body protein synthesis

    Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal

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

Secondary outcomes

  1. Citrulline Rate of appearance

    Time frame: Postabsorptive state during 2 hours

    plasma enrichment of citrulline

  2. Glucose absorption

    Time frame: 7 hours

    Recovery of 3-O-Methyl-D-glucose in the urine.

  3. Gut permeability

    Time frame: 7 hours

    recovery of rhamnose/lactulose in urine

  4. Skeletal and respiratory muscle strength

    Time frame: 1 day

    Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.

  5. Cognitive function

    Time frame: 1 day

    Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism

  6. Fatty acid digestion after feeding

    Time frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal

    Enrichment in palmitic acid and tripalmitin fatty acids in plasma

  7. Protein digestion after feeding

    Time frame: 0,15,30,45,60,75,90,105,120,150,180,210, min post-meal

    Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina

  8. Arginine turnover rate

    Time frame: postabsorptive state during 3 hours

    Arginine enrichment in plasma

  9. Whole body collagen breakdown rate

    Time frame: Postabsorptive state during 3 hours

    Hydroxyproline enrichment in plasma

  10. Tryptophan turnover rate

    Time frame: Postabsorptive state during 3 hours

    Tryptophan enrichment in plasma

  11. Insulin response to feeding

    Time frame: during 3 hours after feeding

    Acute change from postabsorptive state after intake of meal

  12. Fat-free mass

    Time frame: postabsorptive state during 15 min

    Characteristics of study subjects

  13. Myofibrillar protein breakdown rate

    Time frame: 0,15,30,45,60,75,90,105,120,150,180,210 min post-meal

    3methylhistidine enrichment in plasma

  14. Glycine rate of appearance

    Time frame: Postabsorptive state during 3 hours

    glycine enrichment in plasma

  15. Taurine turnover rate

    Time frame: postabsorptive state during 3 hours

    enrichment of taurine in

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

Metabolic and Functional Changes in Relation to Nutritional Status in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2013
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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