HealthyNCT00873951
Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
A study testing Intestinal and metabolic exploration, 15N-labelled intact casein and 15N-labelled hydrolyzed casein in people with Healthy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intestinal and metabolic exploration, 15N-labelled intact casein and 15N-labelled hydrolyzed casein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- BMI between 18 and 25
Who cannot join
- allergy to dairy proteins
- positive serology to AgHbS, HCV or HIV
- pregnancy
- abusive drug or alcohol consumption.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Intestinal and metabolic exploration, 15N-labelled intact casein, 15N-labelled hydrolyzed casein, mixture of AA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal and metabolic explorationOther
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.
15N-labelled intact caseinDietary supplement
standard mixed meal containing 15% of energy as 15N-labelled intact casein
15N-labelled hydrolyzed caseinDietary supplement
standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein
mixture of AADietary supplement
standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine
| Study group | Role | What they receive |
|---|---|---|
| Intact casein | Experimental | Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled intact casein Receives: Other: Intestinal and metabolic exploration; Dietary Supplement: 15N-labelled intact casein |
| Hydrolyzed casein | Experimental | Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein Receives: Other: Intestinal and metabolic exploration; Dietary Supplement: 15N-labelled hydrolyzed casein |
| AA | Experimental | 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 Receives: Other: Intestinal and metabolic exploration; Dietary Supplement: mixture of AA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial metabolic fate of dietary N
Measured: 0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial
Secondary outcomes (1)
Differences in ileal digestibility determination according to the method used
Measured: 8h postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJan 2006
- Primary completionNov 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Riddet Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873951
- Sponsor's protocol ID
- DEGLAIRE CT
- Status last verified
- Oct 2025
- First submitted
- 1 Apr 2009
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31711108Deglaire 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.
PubMed 19692493
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00873951
- Acronym / sponsor ID
- DEGLAIRE CT
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Riddet Institute
- Study start
- Jan 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intact casein | Experimental | Other: Intestinal and metabolic exploration, Dietary Supplement: 15N-labelled intact caseinSubjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled intact casein |
| Hydrolyzed casein | Experimental | Other: Intestinal and metabolic exploration, Dietary Supplement: 15N-labelled hydrolyzed caseinSubjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein |
| AA | Experimental | Other: Intestinal and metabolic exploration, Dietary Supplement: mixture of AASubjects 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subjects
- BMI between 18 and 25
Key exclusion criteria (4 listed)
- allergy to dairy proteins
- positive serology to AgHbS, HCV or HIV
- pregnancy
- abusive drug or alcohol consumption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal and metabolic explorationSubjects 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. | Other | AA, Hydrolyzed casein, Intact casein |
| 15N-labelled intact caseinstandard mixed meal containing 15% of energy as 15N-labelled intact casein | Dietary supplement | Intact casein |
| 15N-labelled hydrolyzed caseinstandard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein | Dietary supplement | Hydrolyzed casein |
| mixture of AAstandard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine | Dietary supplement | AA |
Primary outcome
Postprandial metabolic fate of dietary N
Time frame: 0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial
1 secondary outcome
Differences in ileal digestibility determination according to the method used
Time frame: 8h postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 31711108Deglaire 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.
- Derived from this study: PubMed 19692493Deglaire 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal and metabolic exploration, 15N-labelled intact casein and 15N-labelled hydrolyzed casein in people with Healthy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial metabolic fate of dietary N (time frame: 0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873951, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.