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Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects

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ClinicalTrials.gov Identifier: NCT00931151
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : August 23, 2011
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Robert Benamouzig, Institut National de la Recherche Agronomique

Brief Summary:
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 or disease Intervention/treatment Phase
Overweight Dietary Supplement: Postprandial metabolic and functional measures Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : April 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Endothelial dysfunction [ Time Frame: 0-2-4-6 hours (after meal ingestion) ]

Secondary Outcome Measures :
  1. Postprandial inflammation [ Time Frame: 0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Benamouzig, Professor, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier: NCT00931151     History of Changes
Other Study ID Numbers: SURPROL 2
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: March 2010

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms