Metabolic Impact of Fat Digestion (LIPINFLOX)

Civil Hospices of Lyon

Status: Unknown

Conditions: Obesity

Treatments: Other: All subjects receive three sequences of a standard breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT01249378

2009.563/16

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

10 g non emulsified of milk fat

Active Comparator group

Description:

They are compared using the repeated measurements taken within subjects

Treatment:

Other: All subjects receive three sequences of a standard breakfast

40 g non emulsified of milk fat

Active Comparator group

Description:

The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.

Treatment:

Other: All subjects receive three sequences of a standard breakfast

40 g finely emulsified of milk fat

Active Comparator group

Description:

The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.

Treatment:

Other: All subjects receive three sequences of a standard breakfast