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Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects

This study has been completed.
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Robert Benamouzig, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT00931151
First received: July 1, 2009
Last updated: August 22, 2011
Last verified: March 2010
History of Changes
  Purpose

Dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. This study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.


Condition Intervention
Overweight
 Dietary Supplement: Postprandial metabolic and functional measures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Dietary Proteins
U.S. FDA Resources

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

Primary Outcome Measures:
  • Endothelial dysfunction [ Time Frame: 0-2-4-6 hours (after meal ingestion) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial inflammation [ Time Frame: 0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion) ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Casein
Protein source in the high fat meal is casein
 Dietary Supplement: Postprandial metabolic and functional measures
After ingestion of a high fat meal containing the different protein sources, the subjects undergo a series of measures of endothelial dysfunction and blood and urine sampling for the assessment of proinflammatory cytokines levels and metabolomics determinations.
Experimental: Milk soluble protein
Protein source in the high fat meal are milk soluble protein
 Dietary Supplement: Postprandial metabolic and functional measures
After ingestion of a high fat meal containing the different protein sources, the subjects undergo a series of measures of endothelial dysfunction and blood and urine sampling for the assessment of proinflammatory cytokines levels and metabolomics determinations.
Experimental: Alpha lactalbumin
Protein source in the high fat meal is alpha-lactalbumin
 Dietary Supplement: Postprandial metabolic and functional measures
After ingestion of a high fat meal containing the different protein sources, the subjects undergo a series of measures of endothelial dysfunction and blood and urine sampling for the assessment of proinflammatory cytokines levels and metabolomics determinations.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 25 and 30
  • Waist circumference > 94 cm

Exclusion Criteria:

  • Allergy to milk protein
  • Abusive drug consumption
  • Smoking
  • Hypertension, diabetes
  • High level of physical activity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931151

Locations
France
Centre de recherche sur volontaires
Bobigny, France, 93
Sponsors and Collaborators
Institut National de la Recherche Agronomique
National Research Agency, France
Investigators
Principal Investigator: Robert Benamouzig, MD, Ph. D Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Robert Benamouzig, Professor, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier: NCT00931151     History of Changes
Other Study ID Numbers: SURPROL 2
Study First Received: July 1, 2009
Last Updated: August 22, 2011
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013