Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Riddet Institute
Information provided by:
Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT00873951
First received: April 1, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy
Other: Intestinal and metabolic exploration
Dietary Supplement: 15N-labelled intact casein
Dietary Supplement: 15N-labelled hydrolyzed casein
Dietary Supplement: mixture of AA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:
  • Postprandial metabolic fate of dietary N [ Time Frame: 0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in ileal digestibility determination according to the method used [ Time Frame: 8h postprandial ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Intestinal and metabolic exploration
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.
Dietary Supplement: 15N-labelled intact casein
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
Other: Intestinal and metabolic exploration
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.
Dietary Supplement: 15N-labelled hydrolyzed casein
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
Other: Intestinal and metabolic exploration
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.
Dietary Supplement: mixture of AA
standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00873951

Locations
France
Centre de recherche sur volontaires
Bobigny, France, 93
Sponsors and Collaborators
Institut National de la Recherche Agronomique
Riddet Institute
  More Information

No publications provided by Institut National de la Recherche Agronomique

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Benamouzig, Assistance Publique - Hopitaux de Paris
ClinicalTrials.gov Identifier: NCT00873951     History of Changes
Other Study ID Numbers: DEGLAIRE CT
Study First Received: April 1, 2009
Last Updated: April 1, 2009
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014