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CompletedNCT00931151Updated Aug 23, 2011

Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects

An interventional study of Postprandial metabolic and functional measures in Overweight, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Completed at 1 site in France. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-23.

Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
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Study 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.

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Conditions studied

  • Overweight

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03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 10 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement is the lead sponsor of 49 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to milk protein
  • Abusive drug consumption
  • Smoking
  • Hypertension, diabetes
  • High level of physical activity
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Casein

    Protein source in the high fat meal is casein

    Dietary Supplement: Postprandial metabolic and functional measures

  • Experimental
    Milk soluble protein

    Protein source in the high fat meal are milk soluble protein

    Dietary Supplement: Postprandial metabolic and functional measures

  • Experimental
    Alpha lactalbumin

    Protein source in the high fat meal is alpha-lactalbumin

    Dietary Supplement: Postprandial metabolic and functional measures

Interventions

  • Dietary supplementPostprandial 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.

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What researchers measure

Primary outcomes

  1. Endothelial dysfunction

    Time frame: 0-2-4-6 hours (after meal ingestion)

Secondary outcomes

  1. Postprandial inflammation

    Time frame: 0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion)

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Study locations

1 site
  • Centre de recherche sur volontaires
    Bobigny, 93, France
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References and documents

Publications

  • 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. PubMed 29878266 ↗
  • 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. PubMed 26491119 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2009
First posted
Jul 2, 2009
Start
Apr 2009
Primary completionActual
Jul 2009
CompletionActual
Jul 2009
Last update
Aug 23, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00931151
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
National Research Agency, France
Responsible party
Robert Benamouzig (Professor, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement) — Principal investigator
First posted
Jul 2, 2009
Start date
Apr 2009
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Aug 23, 2011

Study contacts

Robert Benamouzig, MD, Ph. D
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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