NCT00931151

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

August 23, 2011

Status Verified

March 1, 2010

Enrollment Period

3 months

First QC Date

July 1, 2009

Last Update Submit

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

EXPERIMENTAL

Protein source in the high fat meal is casein

Dietary Supplement: Postprandial metabolic and functional measures

Milk soluble protein

EXPERIMENTAL

Protein source in the high fat meal are milk soluble protein

Dietary Supplement: Postprandial metabolic and functional measures

Alpha lactalbumin

EXPERIMENTAL

Protein source in the high fat meal is alpha-lactalbumin

Dietary Supplement: Postprandial metabolic and functional measures

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.

Alpha lactalbuminCaseinMilk soluble protein

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Benamouzig, MD, Ph. D

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

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

Locations