Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedAugust 23, 2011
March 1, 2010
3 months
July 1, 2009
August 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial dysfunction
0-2-4-6 hours (after meal ingestion)
Secondary Outcomes (1)
Postprandial inflammation
0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion)
Study Arms (3)
Casein
EXPERIMENTALProtein source in the high fat meal is casein
Milk soluble protein
EXPERIMENTALProtein source in the high fat meal are milk soluble protein
Alpha lactalbumin
EXPERIMENTALProtein source in the high fat meal is alpha-lactalbumin
Interventions
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 Criteria
You may qualify if:
- BMI between 25 and 30
- Waist circumference \> 94 cm
You may not qualify if:
- Allergy to milk protein
- Abusive drug consumption
- Smoking
- Hypertension, diabetes
- High level of physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de recherche sur volontaires
Bobigny, 93, France
Related Publications (2)
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.
PMID: 29878266DERIVEDMariotti 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.
PMID: 26491119DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Benamouzig, MD, Ph. D
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 2, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
August 23, 2011
Record last verified: 2010-03