NCT00873951

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

April 1, 2009

Last Update Submit

October 1, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Postprandial metabolic fate of dietary N

    0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial

Secondary Outcomes (1)

  • Differences in ileal digestibility determination according to the method used

    8h postprandial

Study Arms (3)

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

Other: Intestinal and metabolic explorationDietary 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

Other: Intestinal and metabolic explorationDietary 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

Other: Intestinal and metabolic explorationDietary Supplement: mixture of AA

Interventions

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.

AAHydrolyzed caseinIntact casein
15N-labelled intact caseinDIETARY_SUPPLEMENT

standard mixed meal containing 15% of energy as 15N-labelled intact casein

Intact casein
15N-labelled hydrolyzed caseinDIETARY_SUPPLEMENT

standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein

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

AA

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • BMI between 18 and 25

You may not qualify if:

  • allergy to dairy proteins
  • positive serology to AgHbS, HCV or HIV
  • pregnancy
  • abusive drug or alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche sur volontaires

Bobigny, 93, France

Location

Related Publications (2)

  • 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.

    PMID: 31711108DERIVED

  • 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.

    PMID: 19692493DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

January 1, 2006

Primary Completion

November 1, 2006

Study Completion

January 1, 2008

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations

FR(1)