Metabolic Impact of Fat Digestion

Not Applicable

• Conditions: Obesity
• Interventions: Other: All subjects receive three sequences of a standard breakfast

• Registration Number: NCT01249378
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-13
• Status Verified: 2010-11
• Study First Submitted QC: 2010-11-26
• Last Update Submitted: 2010-11-26
• Study First Posted: 2010-11-29
• Last Update Posted: 2010-11-29
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
40 g finely emulsified of milk fat	All subjects receive three sequences of a standard breakfast	The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
10 g non emulsified of milk fat	All subjects receive three sequences of a standard breakfast	They are compared using the repeated measurements taken within subjects
40 g non emulsified of milk fat	All subjects receive three sequences of a standard breakfast	The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.

Primary Outcome Measures

Name	Time	Method
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast	four hours

Secondary Outcome Measures

Name	Time	Method
Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma	one day	Subgroups analysis on subjects BMI amount of ingested fat and emulsified or unemulsified state of ingested fat

Trial Locations

Locations (1)

Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA); 🇫🇷 Lyon, 165 chemin du Grand Revoyet, France