Nutritional and Functional Changes in Heart Failure and COPD

NCT01787682 | Completed

• 1 other identifier: 2012-0503
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Chronic Obstructive Pulmonary Disorder

Keywords

CHF; Protein digestion; Fat digestion; Gut function; Glucose absorption; Muscle function

Outcome Measures

Primary Outcomes (1)

• Net whole-body protein synthesis

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

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

Secondary Outcomes (15)

• Citrulline Rate of appearance

  Postabsorptive state during 2 hours

• Glucose absorption

  7 hours

• Gut permeability

  7 hours

• Skeletal and respiratory muscle strength

  1 day

• Cognitive function

  1 day

Study Arms (1)

Boost High Protein

EXPERIMENTAL

Boost high protein with added spirulina

Dietary Supplement: BOOST High Protein

Interventions

BOOST High Protein DIETARY_SUPPLEMENT

Boost High Protein

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

Related Publications (6)

• Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.

  PMID: 38616018 DERIVED

• Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.

  PMID: 37542951 DERIVED

• 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.

  PMID: 36166849 DERIVED

• 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.

  PMID: 34743729 DERIVED

• 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.

  PMID: 32035752 DERIVED

• 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.

  PMID: 28986165 DERIVED

Study Officials

• Marielle PKJ Engelen, PhD

  Texas A&M Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 11, 2013
• Study Start: December 1, 2012
• Primary Completion: September 17, 2017
• Study Completion: September 17, 2017
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

US (1)