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Method To Measure Protein Digestion & Absorption

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02065141
Enrollment
74
Registered
2014-02-17
Start date
2014-11-30
Completion date
2019-01-19
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Pulmonary Disorder, Chronic Obstructive

Keywords

digestion, absorption, protein, amino acids, heart failure, COPD

Brief 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.

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.

Interventions

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

Sponsors

Texas A&M University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

IInclusion and

Exclusion criteria

for study participation: We will enroll subjects (males and females of all races) based on the inclusion/

Design outcomes

Primary

MeasureTime frameDescription
protein metabolism in gutIn postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study dayDigestion of the stable tracers of amino acid measured by plasma samples

Secondary

MeasureTime frameDescription
Body Compositionon screening or study day 1Body composition as measured by Dual-Energy X-ray Absorptiometry
Respiratory muscle strengthon study day 1determined by measurement of maximum breathing pressures
Skeletal muscle strength of hand30 minutes on screening or study daymeasurement of handrip strenth
Skeletal muscle strength of leg30 minutes on screening or study daymeasurement of muscle strength of leg using kin-com machine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026