Metabolic Impact of Fat Digestion (LIPINFLOX)
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
All subjects receive three sequences of a standard breakfast
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Nutrition, Lipid, Digestion, Endotoxemia, Inflammation, Metabolism, Stable Isotope, Obesity
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
Sites / Locations
- Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
10 g non emulsified of milk fat
40 g non emulsified of milk fat
40 g finely emulsified of milk fat
Arm Description
They are compared using the repeated measurements taken within subjects
The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
Outcomes
Primary Outcome Measures
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
Secondary Outcome Measures
Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma
Subgroups analysis on subjects BMI amount of ingested fat and emulsified or unemulsified state of ingested fat
Full Information
NCT ID
NCT01249378
First Posted
July 13, 2010
Last Updated
November 26, 2010
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01249378
Brief Title
Metabolic Impact of Fat Digestion
Acronym
LIPINFLOX
Official Title
Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Nutrition, Lipid, Digestion, Endotoxemia, Inflammation, Metabolism, Stable Isotope, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
10 g non emulsified of milk fat
Arm Type
Active Comparator
Arm Description
They are compared using the repeated measurements taken within subjects
Arm Title
40 g non emulsified of milk fat
Arm Type
Active Comparator
Arm Description
The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
Arm Title
40 g finely emulsified of milk fat
Arm Type
Active Comparator
Arm Description
The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
Intervention Type
Other
Intervention Name(s)
All subjects receive three sequences of a standard breakfast
Intervention Description
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
Primary Outcome Measure Information:
Title
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
Time Frame
four hours
Secondary Outcome Measure Information:
Title
Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma
Description
Subgroups analysis on subjects BMI amount of ingested fat and emulsified or unemulsified state of ingested fat
Time Frame
one day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine LAVILLE, PU-PU
Phone
04 78 86 29 81
Ext
+33
Email
martine.laville@chu-lyon.fr
Facility Information:
Facility Name
Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
City
Lyon
State/Province
165 chemin du Grand Revoyet
ZIP/Postal Code
69495 Pierre Bénite Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Lambert-Porcheron, Dr.
Phone
04 78 86 19 72
Ext
+33
Email
stephanie.lambert-porcheron@chu-lyon.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
28545546
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.
Results Reference
derived
PubMed Identifier
26151336
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.
Results Reference
derived
PubMed Identifier
25916910
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.
Results Reference
derived
PubMed Identifier
23235199
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.
Results Reference
derived
Links:
URL
http://www.crnh-rhone-alpes.fr
Description
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