Metabolic Impact of Fat Digestion (LIPINFLOX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01249378
First received: July 13, 2010
Last updated: November 26, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Obesity
Other: All subjects receive three sequences of a standard breakfast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast [ Time Frame: four hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma [ Time Frame: one day ] [ Designated as safety issue: No ]
    Subgroups analysis on subjects BMI amount of ingested fat and emulsified or unemulsified state of ingested fat


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 g non emulsified of milk fat
They are compared using the repeated measurements taken within subjects
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
Active Comparator: 40 g non emulsified of milk fat
The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
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
Active Comparator: 40 g finely emulsified of milk fat
The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects.
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249378

Contacts
Contact: Martine LAVILLE, PU-PU 04 78 86 29 81 ext +33 martine.laville@chu-lyon.fr

Locations
France
Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA) Recruiting
Lyon, 165 chemin du Grand Revoyet, France, 69495 Pierre Bénite Cedex
Contact: Stéphanie Lambert-Porcheron, Dr.    04 78 86 19 72 ext +33    stephanie.lambert-porcheron@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Additional Information:
No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr. Martine Laville PhD, MD, Hospices Civils de Lyon, Centre de Recherche en Nutrition Humaine -Rhône-Alpes,
ClinicalTrials.gov Identifier: NCT01249378     History of Changes
Other Study ID Numbers: 2009.563/16
Study First Received: July 13, 2010
Last Updated: November 26, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Nutrition
Lipid
Digestion
Endotoxemia
Inflammation
Metabolism
Stable Isotope
Obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014