Metabolic Impact of Fat Digestion (LIPINFLOX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01249378
First received: July 13, 2010
Last updated: November 26, 2010
Last verified: November 2010

July 13, 2010
November 26, 2010
March 2010
February 2013   (final data collection date for primary outcome measure)
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast [ Time Frame: four hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01249378 on ClinicalTrials.gov Archive Site
Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma [ Time Frame: one day ] [ Designated as safety issue: No ]
Subgroups analysis on subjects BMI amount of ingested fat and emulsified or unemulsified state of ingested fat
Same as current
Not Provided
Not Provided
 
Metabolic Impact of Fat Digestion
Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers

In this study, the investigators are interested in investigating how the emulsification state and amount of fat in a meal can modify the kinetics of postprandial lipemia and inflammatory outcomes (including endotoxemia) in obese vs lean subjects.

10 lean and 10 obese volunteers will come 3 times (>3 weeks apart) at the investigation center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non emulsified, or 40 g finely emulsified). 13C triglyceride stable isotopes will allow to follow the metabolic fate of fatty acids and calculate lipid oxidation by breath test. Blood sampling throughout digestion will allow to measure metabolic, lipid and inflammation parameters. Stool will be analysed to determine lipid losses in faeces and to phenotype microbiota.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
Other: All subjects receive three sequences of a standard breakfast

All subjects receive three sequences of a standard breakfast containing :

  • 10 g non emulsified
  • or 40 g non emulsified
  • or 40 g finely emulsified of milk fat with stable isotope (13C triglyceride). The administration order is determined by randomized allocation. The wash-out period is three weeks. There are not diet or exercise interventions. Only, one week before and three days after, the subjects consume neither naturally enriched in 13C foods or pre/probiotics. In addition, three days before and three days after each test, the subjects receive dietary instructions
  • Active Comparator: 10 g non emulsified of milk fat
    They are compared using the repeated measurements taken within subjects
    Intervention: Other: All subjects receive three sequences of a standard breakfast
  • Active Comparator: 40 g non emulsified of milk fat
    The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
    Intervention: Other: All subjects receive three sequences of a standard breakfast
  • Active Comparator: 40 g finely emulsified of milk fat
    The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
    Intervention: Other: All subjects receive three sequences of a standard breakfast
Vors C, Pineau G, Gabert L, Drai J, Louche-Pélissier C, Defoort C, Lairon D, Désage M, Danthine S, Lambert-Porcheron S, Vidal H, Laville M, Michalski MC. Modulating absorption and postprandial handling of dietary fatty acids by structuring fat in the meal: a randomized crossover clinical trial. Am J Clin Nutr. 2013 Jan;97(1):23-36. doi: 10.3945/ajcn.112.043976. Epub 2012 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No smokers
  • BMI 18 to 35 kg/m2
  • Moderate physical activity
  • Safety subject during medical consultation

Exclusion Criteria:

  • Medical history which may affect lipid metabolism and gut microflora (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)
  • Drug use that could affect lipid metabolism and gut microflora (steroids, antilipemic agent, anorectic, antibiotic)
  • Inflammatory or infectious disease in the last three month
  • C Reactive Protein > 20
  • Prebiotic or probiotic high consumers (several times a day)
  • Eating disorder
  • Claustrophobic subjects
Male
18 Years to 45 Years
Yes
Contact: Martine LAVILLE, PU-PU 04 78 86 29 81 ext +33 martine.laville@chu-lyon.fr
France
 
NCT01249378
2009.563/16
Yes
Pr. Martine Laville PhD, MD, Hospices Civils de Lyon, Centre de Recherche en Nutrition Humaine -Rhône-Alpes,
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP