Metabolic Impact of Fat Digestion
LIPINFLOX
Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Mar 2010
Typical duration for not_applicable obesity
1 active site
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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 13, 2010
CompletedFirst Posted
Study publicly available on registry
November 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedNovember 29, 2010
November 1, 2010
2.9 years
July 13, 2010
November 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
four hours
Secondary Outcomes (1)
Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma
one day
Study Arms (3)
10 g non emulsified of milk fat
ACTIVE COMPARATORThey are compared using the repeated measurements taken within subjects
40 g non emulsified of milk fat
ACTIVE COMPARATORThe subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
40 g finely emulsified of milk fat
ACTIVE COMPARATORThe subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
Interventions
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
Eligibility Criteria
You may qualify if:
- No smokers
- BMI 18 to 35 kg/m2
- Moderate physical activity
- Safety subject during medical consultation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
Lyon, 165 Chemin Du Grand Revoyet, 69495 Pierre Bénite Cedex, France
Related Publications (4)
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.
PMID: 28545546DERIVEDVors 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.
PMID: 26151336DERIVEDVors 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.
PMID: 25916910DERIVEDVors 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.
PMID: 23235199DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 13, 2010
First Posted
November 29, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
November 29, 2010
Record last verified: 2010-11