Measuring protein digestibility using a dual-isotope method
Validation of the Dual-isotope Method for Measuring Ileal Protein Digestibility
NA · Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · NCT05426551
This study is testing a new way to measure how well healthy adults can digest protein from a special egg to see if it works better than traditional methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (other) |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT05426551 on ClinicalTrials.gov |
What this trial studies
This study evaluates the digestibility of indispensable amino acids (IAAs) from a specially prepared 2H-labeled hen's egg protein in healthy adults. Participants will consume a test meal containing the labeled protein, and the digestibility will be assessed using both indirect (dual isotope method) and direct (ileal digesta sampling) approaches. The study aims to validate the dual isotope method by comparing its results with direct measurements. A total of 18 healthy volunteers aged 18 to 45 will be recruited for this study, which will take place at the Human Nutrition Research Centre of Avicenne Hospital in France.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men and women aged 18 to 45 with a BMI between 18 and 30.
Not a fit: Patients with any digestive or hepatic pathology, allergies to eggs or latex, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for assessing protein digestibility, which may improve dietary recommendations and food formulations.
How similar studies have performed: While the dual isotope method has been recently developed, this study aims to validate its effectiveness, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18\<BMI\<30 * Healthy * Insured under the French social security system * For women: use of birth control * Signed informed consent Exclusion Criteria: * 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
Where this trial is running
Bobigny
- Centre de Recherche sur Volontaires (CRV) de l'hôpital Avicenne — Bobigny, France (RECRUITING)
Study contacts
- Study coordinator: Juliane Calvez, PhD
- Email: juliane.calvez@agroparistech.fr
- Phone: +33144088677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, amino acid digestibility, dual isotope method, labelled protein