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
Recruitment status was Recruiting
Sponsor:
Hospices Civils de Lyon
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
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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 :
|
|
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 :
|
|
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 :
|
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
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 Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013