Nutritional and Functional Changes in Heart Failure and COPD

Not Applicable

Completed

• Conditions: Chronic Heart Failure; Chronic Obstructive Pulmonary Disorder
• Interventions: Dietary Supplement: BOOST High Protein

• Registration Number: NCT01787682
• Lead Sponsor: Texas A&M University

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-11
• Primary Completion: 2017-09-17
• Study Completion: 2017-09-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boost High Protein	BOOST High Protein	Boost high protein with added spirulina

Primary Outcome Measures

Name	Time	Method
Net whole-body protein synthesis	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 Outcome Measures

Name	Time	Method
Myofibrillar protein breakdown rate	0,15,30,45,60,75,90,105,120,150,180,210 min post-meal	3methylhistidine enrichment in plasma
Whole body collagen breakdown rate	Postabsorptive state during 3 hours	Hydroxyproline enrichment in plasma
Insulin response to feeding	during 3 hours after feeding	Acute change from postabsorptive state after intake of meal
Glucose absorption	7 hours	Recovery of 3-O-Methyl-D-glucose in the urine.
Fat-free mass	postabsorptive state during 15 min	Characteristics of study subjects
Skeletal and respiratory muscle strength	1 day	Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between heart failure patients and healthy controls.
Arginine turnover rate	postabsorptive state during 3 hours	Arginine enrichment in plasma
Taurine turnover rate	postabsorptive state during 3 hours	enrichment of taurine in
Citrulline Rate of appearance	Postabsorptive state during 2 hours	plasma enrichment of citrulline
Gut permeability	7 hours	recovery of rhamnose/lactulose in urine
Fatty acid digestion after feeding	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
Tryptophan turnover rate	Postabsorptive state during 3 hours	Tryptophan enrichment in plasma
Cognitive function	1 day	Outcome of neuro-psychological tests in heart failure patients and healthy controls in relation to the tryptophan metabolism
Protein digestion after feeding	0,15,30,45,60,75,90,105,120,150,180,210, min post-meal	Ratio enrichment free phenylalanine vs phenylalanine from protein spirulina
Glycine rate of appearance	Postabsorptive state during 3 hours	glycine enrichment in plasma

Trial Locations

Locations (1)

Texas A&M University; 🇺🇸 College Station, Texas, United States