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

NCT05426551 | Recruiting

• 1 other identifier: VALDIM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

amino acid digestibility; dual isotope method; labelled protein

Outcome Measures

Primary Outcomes (2)

• Real ileal amino acid digestibility

  The measurements of amino acid concentration (mmol) and their individual 2H enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids that are recovered in the ileal samples are then considered as non absorbed and expressed as % of amino acid ingested, it allows the calculation of real ileal amino acid digestibility (100 - dietary amino acid not absorbed)

  -30 minute to 8 hours after the first meal

• Indirect amino acid digestibility

  The individual amino acid 2H enrichment (atom %) and 13C enrichment (atom %) in the meal and in the plasma from 5 h to 8 h or 0 h to 8 h after the first meal (depending of the group) will be evaluated to calculate their ratio: Ratio meal AAi = 2H meal AAi / 13C meal AAi Ratio plasma AAi = 2H plasma AAi / 13C plasma AAi The ratio of the meal and plasma ratios will be corrected by the known digestibility of spirulina amino acid or free amino acid (in %, depending of the group) to determine the indirect amino acid digestibility of lyophilized egg protein with the following formula: Indirect ileal amino acid digestibility (%) = AAi ileal digestibility spirulina or free AA mix (%) x Ratio plasma AAi / Ratio meal AAi

  -30 minute to 8 hours after the first meal

Secondary Outcomes (3)

• Urinary, fecal and plasma individual amino acid concentration in response to protein ingestion

  -30 minute to 8 hours after the first meal

• Plasma, urinary and fecal peptidome in response to protein ingestion

  -30 minute to 8 hours after the first meal

• Gut microbiota in response to protein ingestion

  Before and 24 hours after meal intake

Study Arms (3)

Bolus-spi

EXPERIMENTAL

The volunteers will consume the test-meal as a bolus in one time at t = 0, with 13C-spirulina as the reference protein

Other: Dual isotope method

Plateau-spi

EXPERIMENTAL

The volunteers will consume the test-meal in a plateau feeding protocol, with 13C-spirulina as the reference protein

Other: Dual isotope method

Plateau-AA

EXPERIMENTAL

The volunteers will consume the test-meal in a plateau feeding protocol, with 13C-free AA mixture as the reference "protein"

Other: Dual isotope method

Interventions

Dual isotope method OTHER

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.

Bolus-spi; Plateau-AA; Plateau-spi

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \<BMI\<30
• Healthy
• Insured under the French social security system
• For women: use of birth control
• Signed informed consent

You may not qualify if:

• Any dietary allergy
• Latex allergy
• Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
• Gluten intolerance
• Anemia
• Use of drugs
• High consumption of alcohol
• Hypertension, diabetes, digestive disease, hepatic or renal disease, severe cardiac disease
• Pregnancy
• High sport practicing (\>7h/wk)
• Blood donation in the 3 months prior to the study
• Participation in a clinical study in the 3 months prior to the study
• No signed informed consent

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead
• St. John's Research Institute: collaborator

Study Sites (1)

Centre de Recherche sur Volontaires (CRV) de l'hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Central Study Contacts

Juliane Calvez, PhD

CONTACT

+33144088677; juliane.calvez@agroparistech.fr

Claire Gaudichon, Prof

CONTACT

+33144081829; claire.gaudichon@agroparistech.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 22, 2022
• Study Start: October 23, 2022
• Primary Completion: May 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

FR (1)