Skip to main content
OpenTrials
Completed

NCT Number: NCT02065141

Method To Measure Protein Digestion & Absorption

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.

Completed

Looking for future studies?

Notify Me

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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

sip feeding with stable isotope infusion

Other

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Primary outcomes

  1. protein metabolism in gut

    Time frame: In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day

    Digestion of the stable tracers of amino acid measured by plasma samples

Secondary outcomes

  1. Body Composition

    Time frame: on screening or study day 1

    Body composition as measured by Dual-Energy X-ray Absorptiometry

  2. Respiratory muscle strength

    Time frame: on study day 1

    determined by measurement of maximum breathing pressures

  3. Skeletal muscle strength of hand

    Time frame: 30 minutes on screening or study day

    measurement of handrip strenth

  4. Skeletal muscle strength of leg

    Time frame: 30 minutes on screening or study day

    measurement of muscle strength of leg using kin-com machine

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2014
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.