Clinical trial NCT01249378: Metabolic Impact of Fat Digestion
Official title: Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Nutrition
Lipid
Digestion
Endotoxemia
Inflammation
Metabolism
Stable Isotope
Obesity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-11-29
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
timeFrame: four hours
Secondary outcomes:
measure: Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma
timeFrame: one day
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
state: 165 chemin du Grand Revoyet
Study officials:
References:
citation: Vors C, Drai J, Pineau G, Laville M, Vidal H, Laugerette F, Michalski MC. Emulsifying dietary fat modulates postprandial endotoxemia associated with chylomicronemia in obese men: a pilot randomized crossover study. Lipids Health Dis. 2017 May 25;16(1):97. doi: 10.1186/s12944-017-0486-6.
citation: Vors C, Pineau G, Drai J, Meugnier E, Pesenti S, Laville M, Laugerette F, Malpuech-Brugere C, Vidal H, Michalski MC. Postprandial Endotoxemia Linked With Chylomicrons and Lipopolysaccharides Handling in Obese Versus Lean Men: A Lipid Dose-Effect Trial. J Clin Endocrinol Metab. 2015 Sep;100(9):3427-35. doi: 10.1210/JC.2015-2518. Epub 2015 Jul 7.
citation: Vors C, Drai J, Gabert L, Pineau G, Laville M, Vidal H, Guichard E, Michalski MC, Feron G. Salivary composition in obese vs normal-weight subjects: towards a role in postprandial lipid metabolism? Int J Obes (Lond). 2015 Sep;39(9):1425-8. doi: 10.1038/ijo.2015.71. Epub 2015 Apr 28.
citation: Vors C, Pineau G, Gabert L, Drai J, Louche-Pelissier C, Defoort C, Lairon D, Desage 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.