Metabolic Impact of Fat Digestion

Obesity Clinical Trial

— LIPINFLOX  

Official title:

Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249378
• Other study ID #: 2009.563/16
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2010
• Last updated: November 26, 2010
• Start date: March 2010
• Est. completion date: February 2013

Study information

• Verified date: November 2010
• Source: Hospices Civils de Lyon
• Contact: Martine LAVILLE, PU-PU
• Phone: 04 78 86 29 81
• Email: martine.laville[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)	Lyon	165 chemin du Grand Revoyet

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast		four hours	No
Secondary	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	one day	No

External Links

•   Link