Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
October 1, 2025 updated by: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further metabolism.
The primary goal of this work was to measure the metabolic fate of intact or hydrolyzed protein using a protein of good nutritional quality, i.e., casein.
A second aim of this study was to assess the true ileal digestibility of dietary protein using different methods including the hydrolyzed casein method and to measure its possible effect on endogenous intestinal N losses in humans.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bobigny, France, 93
- Centre de Recherche sur Volontaires
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy subjects
- BMI between 18 and 25
Exclusion Criteria:
- allergy to dairy proteins
- positive serology to AgHbS, HCV or HIV
- pregnancy
- abusive drug or alcohol consumption.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intact casein
Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled intact casein
|
Subjects are studied for 8h following the ingestion of a standard meal containing 15% of energy as protein.
Intestinal, blood and urine are collected at regular intervals.
standard mixed meal containing 15% of energy as 15N-labelled intact casein
|
|
Experimental: Hydrolyzed casein
Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein
|
Subjects are studied for 8h following the ingestion of a standard meal containing 15% of energy as protein.
Intestinal, blood and urine are collected at regular intervals.
standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein
|
|
Experimental: AA
Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine
|
Subjects are studied for 8h following the ingestion of a standard meal containing 15% of energy as protein.
Intestinal, blood and urine are collected at regular intervals.
standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postprandial metabolic fate of dietary N
Time Frame: 0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial
|
0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Differences in ileal digestibility determination according to the method used
Time Frame: 8h postprandial
|
8h postprandial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Deglaire A, Moughan PJ, Airinei G, Benamouzig R, Tome D. Intact and hydrolyzed casein lead to similar ileal endogenous protein and amino acid flows in adult humans. Am J Clin Nutr. 2020 Jan 1;111(1):90-97. doi: 10.1093/ajcn/nqz268.
- Deglaire A, Fromentin C, Fouillet H, Airinei G, Gaudichon C, Boutry C, Benamouzig R, Moughan PJ, Tome D, Bos C. Hydrolyzed dietary casein as compared with the intact protein reduces postprandial peripheral, but not whole-body, uptake of nitrogen in humans. Am J Clin Nutr. 2009 Oct;90(4):1011-22. doi: 10.3945/ajcn.2009.27548. Epub 2009 Aug 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
April 1, 2009
First Submitted That Met QC Criteria
April 1, 2009
First Posted (Estimated)
April 2, 2009
Study Record Updates
Last Update Posted (Estimated)
October 6, 2025
Last Update Submitted That Met QC Criteria
October 1, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEGLAIRE CT
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