Metabolic Impact of Fat Digestion (LIPINFLOX)

November 26, 2010 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • 165 chemin du Grand Revoyet
      • Lyon, 165 chemin du Grand Revoyet, France, 69495 Pierre Bénite Cedex
        • Recruiting
        • Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
Time Frame: four hours
four hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

November 26, 2010

First Posted (Estimate)

November 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 29, 2010

Last Update Submitted That Met QC Criteria

November 26, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009.563/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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