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Chronic Heart FailureNCT02065141

Method To Measure Protein Digestion & Absorption

A study testing sip feeding with stable isotope infusion in people with Chronic Heart Failure and Pulmonary Disorder, Chronic Obstructive, run by Texas A&M University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
sip feeding with stable isotope infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
Nov 2014to 19 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas A&M University

    College Station, Texas, 77843

Other trials in United States

About this study

Official title: Validation Of A New Method To Simultaneously Measure Protein Digestion And 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.

Read the detailed 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.

Being tested
sip feeding with stable isotope infusion
Keywords
digestion, absorption, protein, amino acids, heart failure, COPD
Medical subject headings
Lung Diseases, Heart Failure, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sip feeding with stable isotope infusionOther

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

Study groups in NCT02065141
Study groupRoleWhat they receive
HealthyOtherscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day: stable isotope infusions with blood draws, sip feed
Receives: Other: sip feeding with stable isotope infusion
Chronic Obstructive Pulmonary DisorderOtherscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical information about them that will help determine study eligibility or can be used for later coding. study day: stable isotope infusions with blood draws, sip feed
Receives: Other: sip feeding with stable isotope infusion
Chronic Heart FailureOtherscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical information about them that will help determine study eligibility or can be used for later coding. study day: stable isotope infusions with blood draws, sip feed
Receives: Other: sip feeding with stable isotope infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. protein metabolism in gut

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

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

Secondary outcomes (4)

  1. Body Composition

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

    Measured: on screening or study day 1

  2. Respiratory muscle strength

    determined by measurement of maximum breathing pressures

    Measured: on study day 1

  3. Skeletal muscle strength of hand

    measurement of handrip strenth

    Measured: 30 minutes on screening or study day

  4. Skeletal muscle strength of leg

    measurement of muscle strength of leg using kin-com machine

    Measured: 30 minutes on screening or study day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion19 Jan 2019
  4. Study completion19 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02065141
Sponsor's protocol ID
2013-0758F
Status last verified
Feb 2022
First submitted
26 Nov 2013
Last updated
7 Feb 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.

    PubMed 42149813

  • Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.

    PubMed 39423760

  • 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.

    PubMed 37542951

Questions about this trial

What is this clinical trial studying?

A study testing sip feeding with stable isotope infusion in people with Chronic Heart Failure and Pulmonary Disorder, Chronic Obstructive, run by Texas A&M University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02065141, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.

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