ObesityLIPINFLOXNCT01249378
Metabolic Impact of Fat Digestion
A study testing All subjects receive three sequences of a standard breakfast in people with Obesity, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- All subjects receive three sequences of a standard breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No smokers
- BMI 18 to 35 kg/m2
- Moderate physical activity
- Safety subject during medical consultation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon,Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
Lyon, 165 Chemin Du Grand Revoyet, 69495 Pierre Bénite Cedex
Stéphanie Lambert-Porcheron, Dr., 04 78 86 19 72 ext. +33, stephanie.lambert-porcheron@chu-lyon.fr
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- All subjects receive three sequences of a standard breakfast
- Keywords
- Nutrition, Lipid, Digestion, Endotoxemia, Inflammation, Metabolism, Stable Isotope, Obesity
- Medical subject headings
- Obesity, Endotoxemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All subjects receive three sequences of a standard breakfastOther
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
| Study group | Role | What they receive |
|---|---|---|
| 10 g non emulsified of milk fat | Active comparator | They are compared using the repeated measurements taken within subjects Receives: Other: All subjects receive three sequences of a standard breakfast |
| 40 g non emulsified of milk fat | Active comparator | The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects. Receives: Other: All subjects receive three sequences of a standard breakfast |
| 40 g finely emulsified of milk fat | Active comparator | The subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects. Receives: Other: All subjects receive three sequences of a standard breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
Measured: four hours
Secondary outcomes (1)
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249378
- Sponsor's protocol ID
- 2009.563/16
- Acronym
- LIPINFLOX
- Status last verified
- Nov 2010
- First submitted
- 13 Jul 2010
- Last updated
- 29 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vors C, Drai J, Pineau G, Laville M, Vidal H, Laugerette F, Michalski MC. Emulsifying dietary fat modulates postprandial endotoxemia associated with chylomicronemia in obese men: a pilot randomized crossover study. Lipids Health Dis. 2017 May 25;16(1):97. doi: 10.1186/s12944-017-0486-6.
PubMed 28545546Vors C, Pineau G, Drai J, Meugnier E, Pesenti S, Laville M, Laugerette F, Malpuech-Brugere C, Vidal H, Michalski MC. Postprandial Endotoxemia Linked With Chylomicrons and Lipopolysaccharides Handling in Obese Versus Lean Men: A Lipid Dose-Effect Trial. J Clin Endocrinol Metab. 2015 Sep;100(9):3427-35. doi: 10.1210/JC.2015-2518. Epub 2015 Jul 7.
PubMed 26151336Vors C, Drai J, Gabert L, Pineau G, Laville M, Vidal H, Guichard E, Michalski MC, Feron G. Salivary composition in obese vs normal-weight subjects: towards a role in postprandial lipid metabolism? Int J Obes (Lond). 2015 Sep;39(9):1425-8. doi: 10.1038/ijo.2015.71. Epub 2015 Apr 28.
PubMed 25916910Vors C, Pineau G, Gabert L, Drai J, Louche-Pelissier C, Defoort C, Lairon D, Desage M, Danthine S, Lambert-Porcheron S, Vidal H, Laville M, Michalski MC. Modulating absorption and postprandial handling of dietary fatty acids by structuring fat in the meal: a randomized crossover clinical trial. Am J Clin Nutr. 2013 Jan;97(1):23-36. doi: 10.3945/ajcn.112.043976. Epub 2012 Dec 12.
PubMed 23235199
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Impact of the Digestion of Fat in Emulsified vs Non-emulsified Form in Lean or Obese Volunteers
- ClinicalTrials.gov ID
- NCT01249378
- Acronym / sponsor ID
- LIPINFLOX / 2009.563/16
- Conditions
- Obesity
- Keywords
- Nutrition, Lipid, Digestion, Endotoxemia, Inflammation, Metabolism, Stable Isotope, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 29 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 g non emulsified of milk fat | Active comparator | Other: All subjects receive three sequences of a standard breakfastThey are compared using the repeated measurements taken within subjects |
| 40 g non emulsified of milk fat | Active comparator | Other: All subjects receive three sequences of a standard breakfastThe subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects. |
| 40 g finely emulsified of milk fat | Active comparator | Other: All subjects receive three sequences of a standard breakfastThe subjects receive three sequences of different breakfasts. They are compared using the repeated measurements taken within subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No smokers
- BMI 18 to 35 kg/m2
- Moderate physical activity
- Safety subject during medical consultation
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All subjects receive three sequences of a standard breakfastAll 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 | Other | 10 g non emulsified of milk fat, 40 g finely emulsified of milk fat, 40 g non emulsified of milk fat |
Primary outcome
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast
Time frame: four hours
1 secondary outcome
Kinectics of: Lipid oxidation plasma metabolite concentrations Endotoxemia and plasma markers of inflammation 13 C-fatty acid appearance in plasma
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2010.
- Derived from this study: PubMed 28545546Vors C, Drai J, Pineau G, Laville M, Vidal H, Laugerette F, Michalski MC. Emulsifying dietary fat modulates postprandial endotoxemia associated with chylomicronemia in obese men: a pilot randomized crossover study. Lipids Health Dis. 2017 May 25;16(1):97. doi: 10.1186/s12944-017-0486-6.
- Derived from this study: PubMed 26151336Vors C, Pineau G, Drai J, Meugnier E, Pesenti S, Laville M, Laugerette F, Malpuech-Brugere C, Vidal H, Michalski MC. Postprandial Endotoxemia Linked With Chylomicrons and Lipopolysaccharides Handling in Obese Versus Lean Men: A Lipid Dose-Effect Trial. J Clin Endocrinol Metab. 2015 Sep;100(9):3427-35. doi: 10.1210/JC.2015-2518. Epub 2015 Jul 7.
- Derived from this study: PubMed 25916910Vors C, Drai J, Gabert L, Pineau G, Laville M, Vidal H, Guichard E, Michalski MC, Feron G. Salivary composition in obese vs normal-weight subjects: towards a role in postprandial lipid metabolism? Int J Obes (Lond). 2015 Sep;39(9):1425-8. doi: 10.1038/ijo.2015.71. Epub 2015 Apr 28.
- Derived from this study: PubMed 23235199Vors C, Pineau G, Gabert L, Drai J, Louche-Pelissier C, Defoort C, Lairon D, Desage M, Danthine S, Lambert-Porcheron S, Vidal H, Laville M, Michalski MC. Modulating absorption and postprandial handling of dietary fatty acids by structuring fat in the meal: a randomized crossover clinical trial. Am J Clin Nutr. 2013 Jan;97(1):23-36. doi: 10.3945/ajcn.112.043976. Epub 2012 Dec 12.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All subjects receive three sequences of a standard breakfast in people with Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine LAVILLE, PU-PU (04 78 86 29 81 ext. +33, martine.laville@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of appearance of plasma triglyceride peak after ingestion of emulsified vs unemulsified fat during breakfast (time frame: four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01249378, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2010.