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Validation of the Dual-isotope Method for Measuring Ileal Protein Digestibility

NCT05426551 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-05

No results posted yet for this study

Summary

The dual isotope method has been recently developed and used to evaluate indispensable amino acid (IAA) digestibility of various protein food such as legumes, eggs and chicken meat in healthy adults and children. The dual isotope method is an indirect method based on the measurement in plasma of absorbed IAA from a deuterium (2H) intrinsically labeled test protein compared against the same IAA of a carbon 13 (13C) intrinsically labeled standard protein of known digestibility or crystalline amino acids (AA) of theoretical 100% digestibility. However, digestibility data estimated with the dual isotope method have not been directly compared with ileal IAA digestibility directly determined through ileal digesta sampling. The goal of this study is to assess the IAA digestibility of intrinsically 2H-hen's egg in healthy volunteers using both indirect and direct methods.

Conditions

  • Healthy

Interventions

OTHER

Dual isotope method

The digestibility of amino acids will be determined within each arm by the collection of ileal digesta owing to naso-ileal intubation device and by plasma samples with the dual isotope method.

Sponsors & Collaborators

  • St. John's Research Institute

    collaborator OTHER

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-23
Primary Completion
2024-05-30
Completion
2024-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426551 on ClinicalTrials.gov