Method To Measure Protein Digestion & Absorption

Chronic Heart Failure Clinical Trial

Official title:

Validation Of A New Method To Simultaneously Measure Protein Digestion And Absorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065141
• Other study ID #: 2013-0758F
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: January 19, 2019

Study information

• Verified date: February 2022
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to validate a new method in healthy volunteers and those diagnosed with COPD and CHF that is able to measure protein digestion and absorption simultaneously. This method is used to quantify digestion and absorption in patients who are suspect of impaired digestion and absorption resulting in loss of nutrients.Findings may be used to develop treatment strategies to improve protein digestion and absorption in these patient groups.

Description:

The study involves 1 screening visit of approximately 1-2 hours and 1 test day of approximately 8 hours. On the study day protein digestion and absorption will be measured using a mixture of amino acids that are made slightly heavier than normal, called stable isotopes. Subjects will receive feeding by sips to monitor changes in digestion and absorption, which can be picked up by stable isotope technology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 19, 2019
• Est. primary completion date: January 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

IInclusion and exclusion criteria for study participation:

We will enroll subjects (males and females of all races) based on the inclusion/exclusion criteria described below. All subjects should be able to walk, sit and stand up indepedently. Screening procedures will be done prior to the study.

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 9 hours
• Diagnosis of CHF; under regular care by cardiologist
• Reduced ejection fraction (<45%) assessed in the past 2 years
• NYHA class II-IV
• 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 subjects:

• Healthy male & female according to the investigator's or appointed staff's judgment
• Age 45 years and older, or 20 - 30 for healthy young group

Exclusion Criteria - all subjects:

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
• Established diagnosis of malignancy
• 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 prior 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
• Already enrolled in another clinical trial and that clinical trial interferes with participating in this study

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Lung Diseases
• Pulmonary Disorder, Chronic Obstructive

Intervention

Other:
• sip feeding with stable isotope infusion
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	protein metabolism in gut	Digestion of the stable tracers of amino acid measured by plasma samples	In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day
Secondary	Body Composition	Body composition as measured by Dual-Energy X-ray Absorptiometry	on screening or study day 1
Secondary	Respiratory muscle strength	determined by measurement of maximum breathing pressures	on study day 1
Secondary	Skeletal muscle strength of hand	measurement of handrip strenth	30 minutes on screening or study day
Secondary	Skeletal muscle strength of leg	measurement of muscle strength of leg using kin-com machine	30 minutes on screening or study day