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Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Postprandial metabolic and functional measures
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de recherche sur volontaires

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Casein

Milk soluble protein

Alpha lactalbumin

Arm Description

Protein source in the high fat meal is casein

Protein source in the high fat meal are milk soluble protein

Protein source in the high fat meal is alpha-lactalbumin

Outcomes

Primary Outcome Measures

Endothelial dysfunction

Secondary Outcome Measures

Postprandial inflammation

Full Information

First Posted
July 1, 2009
Last Updated
August 22, 2011
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
National Research Agency, France
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1. Study Identification

Unique Protocol Identification Number
NCT00931151
Brief Title
Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
National Research Agency, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Casein
Arm Type
Experimental
Arm Description
Protein source in the high fat meal is casein
Arm Title
Milk soluble protein
Arm Type
Experimental
Arm Description
Protein source in the high fat meal are milk soluble protein
Arm Title
Alpha lactalbumin
Arm Type
Experimental
Arm Description
Protein source in the high fat meal is alpha-lactalbumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Postprandial metabolic and functional measures
Intervention Description
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 Measure Information:
Title
Endothelial dysfunction
Time Frame
0-2-4-6 hours (after meal ingestion)
Secondary Outcome Measure Information:
Title
Postprandial inflammation
Time Frame
0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Benamouzig, MD, Ph. D
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche sur volontaires
City
Bobigny
ZIP/Postal Code
93
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29878266
Citation
Pujos-Guillot E, Brandolini-Bunlon M, Fouillet H, Joly C, Martin JF, Huneau JF, Dardevet D, Mariotti F. Metabolomics Reveals that the Type of Protein in a High-Fat Meal Modulates Postprandial Mitochondrial Overload and Incomplete Substrate Oxidation in Healthy Overweight Men. J Nutr. 2018 Jun 1;148(6):876-884. doi: 10.1093/jn/nxy049.
Results Reference
derived
PubMed Identifier
26491119
Citation
Mariotti F, Valette M, Lopez C, Fouillet H, Famelart MH, Mathe V, Airinei G, Benamouzig R, Gaudichon C, Tome D, Tsikas D, Huneau JF. Casein Compared with Whey Proteins Affects the Organization of Dietary Fat during Digestion and Attenuates the Postprandial Triglyceride Response to a Mixed High-Fat Meal in Healthy, Overweight Men. J Nutr. 2015 Dec;145(12):2657-64. doi: 10.3945/jn.115.216812. Epub 2015 Oct 21.
Results Reference
derived

Learn more about this trial

Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects

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