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Completed

NCT Number: NCT00873951

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche sur volontaires

Bobigny, 93, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intestinal and metabolic exploration

Other

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 casein

Dietary Supplement

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

15N-labelled hydrolyzed casein

Dietary Supplement

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

mixture of AA

Dietary Supplement

standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine

Primary outcomes

  1. Postprandial metabolic fate of dietary N

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

Secondary outcomes

  1. Differences in ileal digestibility determination according to the method used

    Time frame: 8h postprandial

Sponsors and collaborators

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Other

Collaborators

  • Riddet Institute

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2008
First posted
Apr 2, 2009
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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